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Providing a Legal

Framework for a National


Public Health Institute (NPHI)
CONTENTS
3 Preface
5 Introduction
6 What Is Meant by a Legal Framework?
7 Potential Benefits of Providing a Legal Framework for
  an NPHI
9 Topics Commonly Addressed in Laws, Decrees, or  
  Regulations Providing a Legal Framework for NPHIs
14 Identifying Conflicts with Existing Legal Documents
15 Choice of Legislative or Executive Branch Approaches for
  Establishing NPHIs
16 Balance Between Detail and Specificity
17 Facilitating Factors and Typical Challenges in Creating a
  Legal Framework

19 Appendices
19 Appendix A. Menu of Considerations for an NPHI Legal
 Framework
30 Appendix B. Steps for Creating a Legal Framework for
  an NPHI
36 Appendix C. Case Studies of Creating Legal Frameworks
  for NPHIs, and the Resultant Laws, Statutes, Decrees,
  or Regulations
36 C1. Guinea-Bissau Case Study, Decree-Law, and
Statutes
50 C2. Liberia Case Study and Law
69 C3. Mozambique Case Study and Decree
77 C4. Nigeria Case Study and Law

Table of Contents
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PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)


PREFACE
National Public Health Institutes (NPHIs) are science-
based governmental institutions or organizations that
promote health by coordinating public health functions and
programs to prevent, detect, and respond to public health
threats. The importance of NPHIs, their core functions and
attributes, and steps for consideration in creating NPHIs are
described in the Framework for Development of National
Public Health Institutes in Africa, published in 2018 by the
Africa Centres for Disease Control.

The Africa CDC is working to establish a new Public Health


Order for Africa, in which Member States are empowered
to strengthen and protect the public health of their peoples.
NPHIs provide the platform to help countries achieve their
public health goals.

Creating an NPHI usually involves bringing together


functions that previously existed in separate organizational
units, sometimes with the addition of functions or units that
did not previously exist in the national government. Many
NPHIs are largely developed from units within Ministries
of Health, which may not have specific legal language
that specifies their functions and authorities. Others have
their origin in research institutes, some of which are
authorized by laws. Regardless of the organizations or
parts of organizations that comprise the new NPHI, a legal
framework that clearly defines what the NPHI will do and
how it will operate is an important step to providing the
clarity of mission, governance, leadership, and finance that
contribute to success.

Developing a legal framework for an NPHI is not easy.


The process requires extensive participation of many
parts of government and key stakeholders, and political
will and commitment of leadership at the highest levels.
Because the legal document that establishes and defines

Preface
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PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)


PREFACE
the NPHI represents a long-term commitment on the part
of government, it requires a vision for the future and the
foresight to address current public health needs and those
of the future.

Africa CDC and African Union Member States are


committed to improving the health of the people of Africa.
Having comprehensive NPHIs supported by strong legal
foundations is an important aspect of this process.

Dr. John Nkengasong


Director – Africa Centres for Disease Control and Prevention

Preface
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PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)


INTRODUCTION
The Framework for Development of National Public Health
Institutes in Africa was published by the Africa CDC in
2018. This landmark document describes the importance
of national public health institutes (NPHIs) for achieving
the vision and mission of the Africa CDC. National public
health institutes provide the platform for integrating and
coordinating public health functions within countries.
Africa CDC is focusing on five strategic pillars that are
essential for public health in Africa:

• Surveillance and disease intelligence


• Emergency preparedness and response
• Laboratory systems and networks
• Information systems
• Public health research
NPHIs are essential for ensuring the implementation of
these pillars.

Increasingly, countries are recognizing that a legal


framework – whether a law, decree, regulation or other
binding document or documents – is an important support
for the NPHI to conduct its activities effectively and
efficiently. The purpose of this document – Providing a
Legal Framework for an NPHI – is to describe the types of
legal mechanisms countries are using to establish NPHIs
or enhance the stature of existing NPHIs and the issues
typically addressed. It also describes processes countries
have used to place NPHIs on sound legal footing, and
some of the typical challenges and facilitating factors
encountered. It includes detailed descriptions of content
that countries might want to include in their documents and
case studies from five countries with varied experiences
creating NPHIs by decree, law, or regulation.

Introduction
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PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)


WHAT IS MEANT
BY A LEGAL
A legal framework for an NPHI is a document or series of
FRAMEWORK? documents, agreed-to by the highest levels of government,
that formally establishes a new or existing NPHI. This means
that the NPHI has a distinct identity, with such elements as
its functions, whether it reports to the Ministry of Health, is
governed by a Board, or reports to both, and parameters
related to its leadership being clearly defined.

Sometimes, the legal framework is comprised of several


documents. For example, there may be a high-level
document – such as a decree – that establishes the
NPHI and provides an overview of mission, functions, and
leadership positions and a statute or other document that
defines the overall structure of the institute and provides
specific authorities to the NPHI, e.g., to develop sub-
national organizational components. These may require
approval by the legislature or by the Council of Ministers.
There are also internal regulations and other documents
that can be approved at the ministerial level.

What is Meant by a Legal Framework?


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PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)


POTENTIAL BENEFITS
OF PROVIDING A LEGAL
Countries develop laws, decrees, regulations, or other legal
FRAMEWORK FOR bases for NPHIs for different reasons. Examples include to
AN NPHI create the NPHI as a new organization that exists outside
existing organizations such as the Ministry of Health,
provide specific authorities to the NPHI, or allow for funding
mechanisms and channels that differ from the usual systems.

Some potential benefits of having a legal framework for an
NPHI include:
• Provide clarity about the NPHI mission, roles, and
responsibilities. Having a legal framework ensures
continuity of the NPHI over time.
• Provide specific authorities to the NPHI. Examples include:
- Working with or coordinating across sectors. For
example, some NPHIs are given authority as the
International Health Regulations focal point or to
coordinate multisectoral leadership groups that
include not only leadership for human health, but also
agriculture, veterinary, environmental, and
other interests.
- Allowing data collection from sub-national levels and
the private sector. Surveillance and investigation of
public health problems can be facilitated when the
NPHI is explicitly empowered to collect data and other
information from all levels of government and from
organizations that are not part of government.
- Providing for special authorities in extenuating
circumstances. This includes being able to quarantine
or isolate individuals during extraordinary health
events if essential for protecting the public’s health
and to circumvent regular controls on hiring and
procurement during emergencies.
• Ensure continuity of leadership when political changes
occur. For example, legal documents often describe terms
for NPHI Directors and Deputy Directors, which often do
not overlap the duration of terms for elected officials.

Potential Benefits of Providing a Legal


Framework for an NPHI PAGE | 7

PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)


POTENTIAL BENEFITS
OF PROVIDING A LEGAL
• Provide a strong basis for NPHI funding. For example,
FRAMEWORK FOR NPHIs can be authorized to obtain their budgets directly
AN NPHI from the Ministry of Finance instead of being part of the
Ministry of Health budget request. They may also authorize
creation of foundations that can receive private funds to
support the mission of the NPHI and allow NPHIs to collect
fees for services rendered.

Potential Benefits of Providing a Legal


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Framework for an NPHI
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
TOPICS COMMONLY
ADDRESSED IN
The contents of NPHI legal framework documents and
LAWS, DECREES, the level of detail will vary by country. At a minimum, most
OR REGULATIONS legal documents will include a statement of establishment
PROVIDING A LEGAL of the NPHI, a description of the functions, and information
FRAMEWORK about the governance structure. Appendix A describes
some of the legal domains and attributes often addressed
FOR NPHIS
in the legal documents establishing an NPHI. The domains
described in detail in Appendix A are shown in the Box.

Below are examples of topics that have been included in


NPHI legal framework documents. Most of these domains
are described in Appendix A in more detail.

Domains to consider when developing a


• Definitions
legal framework for an NPHI
Many legal frameworks will include definitions of terms
I. Establishment – The legal instrument used in the framework.
establishes the NPHI
II. Functions – The legal instrument • Establishment
describes the core functions of the NPHI, This section often includes an overview of the legal
including authorities needed to achieve document -- topics such as the purpose of the Act,
them.
Decree, or Regulation; and, if relevant, establishment
III. Leadership – The legal instrument
of the NPHI as a corporate body (e.g., for parastatal
establishes the leadership structure of the
NPHI. organizations) or as an autonomous government institute.
IV. Oversight and Advisory Boards – It may include provisions for the NPHI to establish sub-
The legal instrument establishes NPHI national, e.g., regional centres.
oversight and advisory boards.
V. Accountability and Reporting – The • Governance of the NPHI and relationship to the Minister
legal instrument establishes accountability
of Health
and reporting mechanisms.
An important issue is whether the NPHI is a line
VI. Financial Resources and Their Use –
The legal instrument authorizes funding agency, reporting to the Minister of Health, or exists
and addresses certain aspects related to as a parastatal, or has aspects of both. Some issues
the use of funds. related to these decisions are discussed in the IANPHI
VII. Effective Date – The legal instrument Best Practices Series document: “Legal Mandates and
establishes an effective date. Governance for NPHIs” (http://www.ianphi.org/_includes/
VIII. Repeal, Amendment, or Transfer of
documents/Legislation%20BP%20Guidance%20%20.pdf).
Prior Authorities
If the organization has oversight by a Board of Directors,

Topics Commonly Addressed in Laws, Decrees,


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or Regulations Providing a Legal Framework for NPHIs
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
TOPICS COMMONLY
ADDRESSED IN
the composition and terms of that Board and other
LAWS, DECREES, aspects related to its functioning are often included in the
OR REGULATIONS legal document.
PROVIDING A LEGAL
FRAMEWORK Regardless of NPHI governance, the relationship to the
Minister of Health is usually discussed. If the NPHI is a
FOR NPHIS
line agency, the Director of the NPHI will usually report
to the Minister of Health or a senior Ministry official. If the
NPHI is a parastatal organization and reports to a Board
of Directors, the Ministry of Health is usually represented
among Board members and may chair the Board, and the
Minister may be provided certain authorities, for example,
to receive NPHI data or reports.

• Functions of the NPHI and related authorities


The NPHI functions are often based on or similar to the
NPHI Core Functions (CFs) Africa CDC NPHI Core Functions, for example, conducting
surveillance and public health research. The Core
CF 1. Population Health and Health- Functions described in the Framework for Development
Related Indicators
of National Public Health Institutes in Africa, published by
CF 2. Public Health Laboratory and
the Africa CDC, are shown in the Box.
Surveillance Systems, and Emergency
Preparedness and Response
CF 3. Disease Prevention and Health Many NPHIs have responsibility for public health
Promotion emergency preparedness and response. The legal
CF 4. Advocacy, Communication and document creating the NPHI may include authorization for
Social Mobilization cross-cutting efforts, such as coordination of multisectoral
CF 5. Policies and Plans that Support
committees.
Individual and Community Health Efforts
CF 6. Health Protection and Support for
Regulation and Enforcement
Some NPHIs have authorities that are only relevant during
CF 7. Evaluation and Promotion of extreme emergencies, such as the authority to quarantine
Equitable Access to Services or isolate individuals or groups of individuals or to utilize
CF 8. Public Health Workforce alternative channels for hiring and procurement.
Development
CF 9. Evaluation, Prevention, and Control
Particularly if the legal framework will move functions from
of Public Health Issues in Clinical Settings
the Ministry of Health or other government organizations
CF 10. Research in Public Health
into the NPHI, it may be helpful to explicitly state which

Topics Commonly Addressed in Laws, Decrees,


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or Regulations Providing a Legal Framework for NPHIs
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
TOPICS COMMONLY
ADDRESSED IN
functions will be moved and which will be retained
LAWS, DECREES, elsewhere.
OR REGULATIONS
PROVIDING A LEGAL • Role in relation to subnational levels and private entities
FRAMEWORK The legal framework may provide for or specify
authorities and limits related to sub-national levels of
FOR NPHIS
the public health system or private organizations. For
example, NPHIs are sometimes given explicit authority
to collect data for surveillance from subnational levels
and private health-care providers, and to collect
information with personal identifiers as part of outbreak
investigations. They may also be allowed to take on
responsibilities that are devolved to sub-national levels
during major emergencies that could have national or
international impacts. NPHIs may be able to enter into
contracts or other legally-binding documents, second or
receive staff, share facilities, and otherwise collaborate
and coordinate with private organizations.

• Leadership of the NPHI


Various terms are used to describe the leader of the
NPHI, including Director, Director-General, President, and
Chief Executive Officer. The legal documents establishing
the NPHI often include information about the required
competencies of the Director and Deputy Director of the
NPHI, how they will be selected, and their terms of service.

• Oversight and advisory boards, and other bodies


supporting the work of the NPHI
The legal framework may mandate or otherwise authorize
certain committees and boards designed to inform and
support the work of the NPHI. For example, the framework
can call for a scientific advisory board and can provide
guidance on membership, functions and activities.

Topics Commonly Addressed in Laws, Decrees,


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or Regulations Providing a Legal Framework for NPHIs
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
TOPICS COMMONLY
ADDRESSED IN
• Requirements for NPHI reporting and accountability
LAWS, DECREES, Annual reporting may be required, both on activities and
OR REGULATIONS on finances including audits.
PROVIDING A LEGAL
FRAMEWORK • Financial resources
The legal framework provides clarity on sources of NPHI
FOR NPHIS
funding. It usually allows for appropriations from the
national budgets and may articulate the process that
the NPHI will use to submit its budget, e.g., through the
Ministry of Health or working directly through the Ministry
of Finance. It may authorize the NPHI to raise funds
through providing services, selling publications, or other
activities, and may allow for it to accept funds from public
or private entities, national or foreign. Sometimes it will
allow the creation of a foundation specifically to raise
funds that support the NPHI’s mission, or partnership with
organizations that can raise such funds.

The legal framework may also address issues related


to the use of resources. Besides addressing purchase
of equipment and supplies, purchase or renovation of
property and buildings, and contracting, it may include
provisions that provide the NPHI with flexibility related to
human resources. This can include payment of salaries,
authority to second staff to other organizations or
participate in staff exchanges, and authority to provide
staff with long-term training opportunities.

• Date the legal document goes into effect


The effective or commencement date (i.e., the date the
legal document has force of law) will be stipulated and
any prerequisites for the legal document to go into effect
will be made clear.

Topics Commonly Addressed in Laws, Decrees,


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or Regulations Providing a Legal Framework for NPHIs
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
TOPICS COMMONLY
ADDRESSED IN
• Legal documents that will be repealed, explicit transfers
LAWS, DECREES, of functions and resources
OR REGULATIONS Because NPHIs are often built on pre-existing
PROVIDING A LEGAL organizations, there may be existing legislation, rules, or
FRAMEWORK regulations that may not be aligned with the new legal
framework. These may need to be repealed or modified. If
FOR NPHIS
human, financial, or other resources are to be transferred,
the terms for these transfers may be addressed. The legal
framework may also explicitly state what functions are
being transferred, e.g., from the Ministry of Health, and
what functions are remaining in other organizations.

Topics Commonly Addressed in Laws, Decrees,


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or Regulations Providing a Legal Framework for NPHIs
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
IDENTIFYING
CONFLICTS WITH
An important step in developing a legal framework for
EXISTING LEGAL an NPHI is to identify existing legal documents that may
DOCUMENTS conflict with the new one. For example, creating an NPHI
includes moving functions, staff, property, and other
resources from the Ministry of Health or other organizations
to the NPHI. If these are assigned by law or decree
elsewhere, the NPHI legal framework should include
explicit language addressing the change. Another example
that may require explicit modification of pre-existing laws
or decrees is the authorization for an NPHI that is a line
agency in the Ministry of Health to submit its budget directly
to the Ministry of Finance.

Identifying Conflicts with Existing Legal Documents


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PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)


CHOICE OF
LEGISLATIVE OR
Countries have used different approaches to establishing
EXECUTIVE BRANCH legal bases for their NPHIs. Some, for example, Ethiopia and
APPROACHES FOR Mozambique, have used processes that mainly involved
ESTABLISHING NPHIS the Executive Branch of government, typically requiring
approval of a Council of Ministers and the President.
Others, such as Liberia, have legislation, passed by the
Legislative Branch. Even if the NPHI is established through
a law, there may be a need for additional, more detailed
regulations and other legal documents, usually created in
the Executive Branch, to provide the detail required for the
NPHI to function.

Theoretically, a legal framework for the NPHI that passes


through the Executive Branch only may be easier to
dismantle than one that passes through a legislature.
However, creating a legal framework that requires
legislative approval may take longer and may be delayed
due to political shifts, particularly if the process takes a long
time. Both Executive and Legislative Branch approaches
have been used successfully in Africa.

Choice of Legislative or Executive Branch


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Approaches for Establishing NPHIs
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
BALANCE
BETWEEN DETAIL
One of the challenges in drafting a legal document
AND SPECIFICITY establishing an NPHI is developing a document that is
specific enough to provide the necessary framework for
the NPHI, but not so specific that it will soon become
outdated. For example, providing extensive detail about
organizational structure may help in estimating costs for the
NPHI and clarify how it will function, but as responsibilities
are added or additional units created, amendments may be
needed. Passage of amendments through the legislature
or Council of Ministers is usually time-consuming and
can be difficult. Therefore, many countries opt for a more
general foundational document, which is supplemented by
additional, more detailed documents that are more easily
approved and modified. This approach allows the NPHI to
adapt as needs change.

Balance Between Detail and Specificity


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PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)


FACILITATING
FACTORS AND TYPICAL
Regardless of the legal mechanism used, support from
CHALLENGES IN the highest levels of government is essential. Because
CREATING A LEGAL authorities and other aspects included in legal documents
FRAMEWORK that create or empower an NPHI have implications for the
Ministry of Health and other agencies, the support of the
Minister of Health and other high-level officials from other
Ministries is essential.

Developing a legal framework for an NPHI requires


extensive discussion and negotiation, with stakeholder
involvement from the earliest stages. This includes
stakeholders both in and outside of government. Taking the
time to ensure all critical stakeholders have input and that
their concerns are heard helps build support for the NPHI.
Creating an NPHI may be facilitated by the broad thinking
and government-wide consultations that occur during
periods of health system or government-wide reform.

Legal documents for NPHIs often consolidate functions


that had previously been dispersed among multiple
organizations. Accomplishing consolidation with minimal
disruption of well-functioning efforts is essential.

Consolidation means that some organizations may need to


relinquish control of activities, personnel, and resources.
Discussions about what the NPHI will include can be
difficult. Having an agreed-to vision and stakeholder
support for the NPHI and its potential impact on public
health can help resolve some of the initial disagreements.

The importance of high-level leadership and support cannot be


overstated. High-level support is essential to ensure decisions
are made that keep the vision for public health in mind, rather
than the interests of specific individuals or organizations. This
is discussed in more detail in the Framework for Development
of National Public Health Institutes.

Facilitating Factors and Typical Challenges in


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Creating a Legal Framework
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
FACILITATING
FACTORS AND TYPICAL
Particularly if the legal framework will permit the NPHI to
CHALLENGES IN use alternative administrative mechanisms to those used
CREATING A LEGAL by the Ministry of Health, e.g., using alternatives to hiring
FRAMEWORK through the civil service system, there may be concerns
about how expensive the NPHI will be. For example, some
parastatal organizations allow for higher salaries and more
flexible procurement systems than are available through the
Ministry of Health. However, the flexibility and options for
funding provided by a parastatal may prove beneficial in the
longer term. A business plan can be helpful in facilitating
discussion about cost and financial issues. The IANPHI
Best Practices Series includes a discussion of “Building a
Business Case for NPHI Creation” (http://www.ianphi.org/_
includes/documents/Business%20case_BP%20).

Facilitating Factors and Typical Challenges in


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Creating a Legal Framework
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
APPENDICES
APPENDIX A. MENU OF CONSIDERATIONS FOR AN
NPHI LEGAL FRAMEWORK
This Appendix describes eight legal domains, or major
Fig. 1- Domains to consider when categories, frequently included in the legal instruments
developing a legal framework for an NPHI
establishing NPHIs. Under seven of these domains are
listed attributes – further detail about what might be
I. Establishment – The legal instrument
establishes the NPHI. included in the domains. Note that in some cases the
II. Functions – The legal instrument attributes provide options, not all of which will be relevant.
describes the core functions of the NPHI, For example, attribute 1.2 establishes the NPHI as a
including authorities needed to achieve parastatal entity, and attribute 1.3 establishes it as a line
them. agency in the Ministry of Health. The NPHI should choose
III. Leadership – The legal instrument
which if any of the options is most appropriate.
establishes the leadership structure of the
NPHI.
IV. Oversight and Advisory Boards – This list is not meant to be exhaustive. Which elements
The legal instrument establishes NPHI are included in an NPHI’s legal documents, how they are
oversight and advisory boards. organized, the order in which they appear, and the exact
V. Accountability and Reporting – The language used will depend on the NPHI and the country
legal instrument establishes accountability context.
and reporting mechanisms.
VI. Financial Resources and Their Use –
Importantly, the information contained in Appendix A is
The legal instrument authorizes funding
and addresses certain aspects related to not intended as a model legal instrument. Examples of
the use of funds the specific language used by existing NPHI creation
VII. Effective Date – The legal instrument documents are in the laws, decrees, and regulations in
establishes an effective date. Appendix C and in legal documents found at http://www.
VIII. Repeal, Amendment, or Transfer of ianphi.org/resources/toolkit/nphilegislation.html.
Prior Authorities

Note that many NPHIs have multiple documents that


comprise their legal framework. The focus of this Appendix
is on a higher-level document, such as might be passed by
the national legislature or Council of Ministers. Some issues
addressed here and other more detailed content (e.g.,
related to specific day-to-day operations of the NPHI) are
often addressed in documents requiring Ministerial or other
lower-level approvals, allowing for easier change as the
country’s needs or the NPHI itself changes.

Appendix A. NPHI Legal Framework:


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Menu of Considerations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
APPENDICES
DEFINITIONS
Fig. 2- Legal domains and attributes for
establishment of an NPHI* Legal frameworks establishing NPHIs often include
definitions to clarify the meaning of terms included in
Domain 1: The legal instrument the legal instrument. This section provides the accepted
establishes the NPHI** definitions for terminology used throughout the legal
instrument, including terms that do not have a standardly
1.1 – The legal instrument establishes an
accepted meaning. If a term is used anywhere in the legal
NPHI
1.2 – The legal instrument establishes the
instrument, it should be used consistently throughout.
NPHI as a parastatal entity
1.2.1 – The legal instrument articulates I. Establishment
a reporting structure
In some legal documents, an early statement establishes
1.2.2 – The legal instrument describes
the NPHI. Usually the legal framework will define the
functions and operations
1.2.2.1 – The legal instrument
NPHI as a line agency, reporting to the Minister of Health;
describes the scope of duties a parastatal entity; or an organization that has aspects
1.2.2.2 – The legal instrument of both. This may come at the beginning of the legal
includes limitations on authorities document, as part of the establishment of the NPHI, or
1.3 – The legal instrument incorporates or later. Some issues related to governance of NPHIs are
establishes the NPHI within the existing
discussed in the IANPHI Best Practices Series document:
Ministry of Health organization
“Legal Mandates and Governance for NPHIs” (http://www.
1.3.1 – The legal instrument articulates
a reporting structure
ianphi.org/_includes/documents/Legislation%20BP%20
1.3.2 – The legal instrument describes Guidance%20%20.pdf).
functions and operations
1.3.2.1 – The legal instrument II. Functions
describes the scope of duties
Functions commonly addressed in creating a legal
1.3.2.2 – The legal instrument
includes limitations on authorities
framework for an NPHI include public health research,
surveillance, laboratory services, public health emergency
management, and use of evidence to formulate policy
* Legal domains correspond to the major
areas of law recommendations. These are usually consistent with
** Attributes provide more detail about the functions described in detail in the Framework for
what could be covered in the legal Development of National Public Health Institutes in Africa,
instrument
published in 2018 by the Africa CDC. Sometimes, NPHI
establishment documents provide extensive detail about
the NPHI’s functions. For example, a document might
include over ten statements related to the role of the NPHI
in laboratory-related efforts. Other times, for example, if the

Appendix A. NPHI Legal Framework:


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Menu of Considerations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
APPENDICES
role of the NPHI is expected to expand substantially or a
transition period to full NPHI functioning is expected, the
functions are left more general, so that amendments will not
be needed. Some broad legal considerations related to the
function of an NPHI include:

1. Breadth of topics and functions covered by the NPHI.


Many NPHIs in Africa begin with a focus on communicable
diseases. However, they often are expanding to address
non-communicable diseases, injury, and violence. In
addition, NPHIs often have responsibilities related to
certain common functions like surveillance, research,
laboratory, and public health emergency management,
among others.

2. Authority to collect, protect, and share data, specimens,


and other information. The ability of NPHIs to collect data
and specimens from subnational levels and private-sector
entities, e.g., for surveillance, is often facilitated by having
legal authority to do so. Language may also be included
about requirements, restrictions, and protections related
to human subjects and restrictions or requirements for
protection or sharing of information or specimens. The
legal instrument may also include restrictions on specific
kinds of data, and additional requirements for data security
and data sharing. It may include language about ownership
of intellectual property generated by work conducted
within the NPHI or supported using NPHI resources.

3. Authority to lead multi-sectoral efforts. Many NPHIs have


responsibility for public health emergency preparedness
and response and have authorizing language allowing
them to develop interagency committees, conduct
exercises, and do other cross-cutting activities to reduce
the impact of emergencies.

Appendix A. NPHI Legal Framework:


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Menu of Considerations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
APPENDICES
4. Use of data to guide policy. Although responsibility for
Fig. 3- Legal domain and attributes
related to the functions of an NPHI
policymaking tends to remain with the Minister of Health,
the NPHI is often stated to have a role in conducting and
Domain 2: The legal instrument financing research, synthesizing information for policy
describes the core functions of the NPHI
purposes and recommending evidence-based policies to
2.1 – The legal instrument designates the Minister.
administrative roles and functions
2.1.1 – The legal instrument includes
authority to manage funds or distribute
5. Laboratories. If the NPHI has a central or national
funds to others laboratory, the functions of that laboratory may be
2.1.2 – The legal instrument grants rule articulated. These may include providing reference
making or regulatory authority to the
NPHI
or specialty laboratory services, managing a national
2.2 – The legal instrument designates laboratory network, and supporting laboratory quality
roles and functions for laboratory systems throughout the country.
2.2.1 – The legal instrument
establishes a public health laboratory
or laboratory network 6. Special authorities during public health emergencies.
2.2.1.1 – The legal instrument Many NPHIs have authorities that are only relevant during
describes diagnostic testing
capacity at national, regional,
extreme emergencies, such as the authority to quarantine
district, or community levels or isolate individuals or groups of individuals or to utilize
2.2.1.2 – The legal instrument alternative channels for hiring, procurement, or regional
describes collection of laboratory
data
collaboration. Sometimes, being able to act on these
2.2.1.2.1 – The legal instrument authorities requires development of criteria for action and
includes data sharing concurrence by the Ministry of Health.
requirements
2.2.1.3 – The legal instrument
allows for specimen collection III. Leadership and Control
2.2.1.3.1 – The legal instrument
includes provisions for
The legal document usually indicates the title for the
regulation of specimen leader of the NPHI. Typical titles are Director, Director-
collection General, President, and Chief Executive Officer, but may
2.2.1.3.2 – The legal instrument
includes provisions for
vary depending on structure. In some cases, processes
regulation of specimen transport for appointment and qualifications may be specified
2.2.1.3.3 – The legal instrument down to the level of Department Directors or may identify
includes provisions for
regulation of specimen storage
specific positions (e.g., EOC Director). The IANPHI “Best
2.3 – The legal instrument designates Practices Series: Recruiting an NPHI Director” describes
roles and functions for surveillance some considerations regarding duties and qualifications
systems
of an NPHI Director (http://www.ianphi.org/_includes/
documents/Director%20BP%20Guidance%20.pdf). Specific
considerations include:

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1. Qualifications of the NPHI leadership. The legal
2.3.1 – The legal instrument permits
framework often includes information about the required
activities for the prevention and control
of infectious diseases competencies of the Director, Deputy Director, and
2.3.1.1 – The legal instrument potentially other positions of the NPHI. This usually
permits data collection on
includes requirements related to education, public health
infectious diseases
2.3.1.2 – The legal instrument practice, and management experience. If included in
includes provisions for data privacy the document, requirements should strike a balance
and security
ensuring the candidate has the experience and skills to
2.3.1.3 – The legal instrument
includes diagnostic capacity for lead the NPHI while being broad enough to allow for the
detection and identification of recruitment of diverse candidates.
infectious diseases
2.3.1.4 – The legal instrument
allows for systematic, ongoing 2. Selection and approval process. The legal framework
collection of data for public health describes how the Director, and other senior positions
purposes
will be selected, including who will make the appointment
2.3.1.5 – The legal instrument
includes provisions for mandatory (e.g., the President, on the recommendation of the Board
reporting within the country of Directors).
2.3.1.6 – The legal instrument
includes provisions for international
reporting 3. Tenure. When director and deputy terms of service are
2.3.2 – The legal instrument permits specified (often as four- or five-year, renewable terms),
activities for prevention and control of
the stability of the NPHI is increased, as leadership and
non-communicable diseases
2.3.2.1 – The legal instrument direction are less subject to political considerations, which
permits data collection on non- is important for a science-based organization like an
communicable diseases
NPHI.
2.3.2.2 – The legal instrument
includes diagnostic capacity for
detection and identification of non- 4. Removal from office. Clarifying what constitutes
communicable diseases
grounds for removing an NPHI Director and the process
2.3.2.3 – The legal instrument
allows for systematic, ongoing for doing so, including who makes the final decision,
collection of data for public health also contributes to reducing the risk of politicizing this
purposes
position.
2.3.2.4 – The legal instrument
includes provisions for the
development of health indicators
2.3.2.5 – The legal instrument
includes provisions for reporting
within the country
2.4 – The legal instrument permits
activities for epidemiologic investigation

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IV. Oversight and Advisory Boards
2.5 – The legal instrument permits
activities for a public health emergency Legal frameworks for National Public Health Institutes,
response function within the NPHI particularly those that are parastatal entities, may include
2.5.1 – The legal instrument allows for
emergency preparedness activities
provisions for oversight by a Board of Directors. In addition,
2.5.1.1 – The legal instrument NPHIs may also be required to establish boards with specific
authorizes the development of regulatory, oversight, or advisory functions. In these cases,
public health response plans and/or
procedures
other matters related to the authorization, selection of
2.5.1.2 – The legal instrument members, and aspects related to the operation and business
authorizes establishment of an of a Board of Directors or other regulatory, oversight, or
Incident command structure for
public health emergencies
advisory boards may be included. An institutional review
2.5.1.3 – The legal instrument board is an example of a board with an oversight and
authorizes public health emergency regulatory function. Advisory boards without regulatory or
response training
2.5.2 – The legal instrument makes
oversight functions, such as scientific advisory boards, may
provisions for public health surveillance also be established to provide advice, but they do not have
during times of emergencies responsibilities related to governance. Legal considerations
2.5.3 – The legal instrument provides
for coordination and communication
related to establishment of boards can include:
between and among sectors during
public health emergencies 1. The composition of the board. Legal guidelines pertaining
2.5.3.1 – The legal instrument
includes provisions related to multi-
to the composition of the board may speak to the
sectoral communication relationship to and participation by high-level leadership
2.5.3.2 – The legal instrument from the Ministry of Health as well as other governmental
designation of a focal point for
communication
entities. There may be requirements to include board
2.5.4 – The legal instrument describes members from academia or other sectors as well
certain powers related to public health as provisions for non-voting or “ex-officio” member
emergency response
2.5.4.1 – The legal instrument
designation and participation.
makes provision for the declaration
of a public health emergency 2. A process for member selection. The legal framework
2.5.4.2 – The legal instrument
establishes procedures to enable
may stipulate certain processes or requirements for the
quarantine of individuals or selection of oversight or advisory board members, or
infectious agents during times of it may designate authority to others to develop and/or
emergency
2.5.4.3 – The legal instrument
oversee processes for the selection of board members.
establishes procedures to enable
isolation of individuals or infectious 3. Tenure of members. The legal framework may stipulate
agents during times of emergency
2.6 – The legal instrument designated
terms of service. In practice, terms of service may be
roles and functions for disease prevention staggered, and such practice could be reflected in the
legal document.

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4. The role of boards. In authorizing boards or similar
and health promotion entities, the legal framework may specify the role in
2.6.1 – The legal instrument authorizes
behavioral health and communication oversight, governance, or advisory functions. Governance
activities boards may also have authority to review or approval
2.6.2 – The legal instrument requires of budgets or budget proposals, have broad or specific
policy development for health
promotion and for the prevention and functions to promulgate regulations, and may have
control of disease responsibilities for ensuring safe and ethical conduct in
2.6.3 – The legal instrument specifies the operationalization of key public health activities such
creation of a health promotion function
2.7 – The legal instrument designates as research.
the roles of and functions for workforce
development 5. Issues related to functioning. A legal framework may
2.7.1 – The legal instrument requires
Identification of public health address issues including periodicity of board meetings,
workforce needs whether allowance or payments to board members are
2.7.2 – The legal instrument authorizes permitted, requirements for recordkeeping, how board
public health workforce training
activities decisions are to be made, and what constitutes a quorum.
2.7.3 – The legal instrument describes
other workforce capacity building
activities V. Accountability and Reporting
2.8 – The legal instrument establishes
Whether reporting to a Minister or a Board or both, the
roles and functions for public health
research and development NPHI generally will be responsible for reporting on topics
2.8.1 – The legal instrument authorizes such as its activities, future plans, and finances, typically on
public health research activities
an annual basis. Many NPHIs are subject to annual auditing,
2.8.2 – The legal instrument authorizes
public health monitoring and and some are required to make certain information publicly
evaluation activities available.

Fig. 4 – Legal domain and attributes


VI. Financial Resources and Their Use
related to leadership and control of an NPHI legal frameworks can authorize funding, set
NPHI
parameters for the use of funds, and establish certain
Domain 3: The legal instrument budgeting and managing practices. The framework may
establishes the leadership structure of also include parameters for the use of funds for hiring
the NPHI
of staff, staff transfers, and secondments. Broad legal
3.1 – The legal instrument establishes the considerations include:
role of NPHI Director
3.1.1 – The legal instrument describes
processes for appointment,
1. Allowable sources of funding. Legal frameworks can
resignation, or removal or addresses authorize funding, either from the state’s budget, through
tenure the ability to raise funds from other sources or through

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both. Appropriations from the state’s budget may be
3.1.2 – The legal instrument describes authorized up to a certain amount, or for a certain period
the role, duty, and authority of the
Director of years. The ability to raise funds through other sources,
3.1.2.1 – The legal instrument such as through the collection of fees or through the
describes limitations on authority of receipt of gifts may also have similar time or resource limits.
the Director
3.1.3 – The legal instrument establishes
professional qualifications or other 2. Who can provide funding. Explicit language may be
competencies for the NPHI Director included that allows the NPHI to accept funds from
3.2 – The legal instrument establishes the
role of NPHI Deputy Director public or private entities (e.g., development assistance
3.2.1 – The legal instrument and gifts). Language may also be included to determine
describes processes for appointment, whether funds can be accepted from foreign institutions
resignation, or removal or addresses
tenure or organizations.
3.2.2 – The legal instrument describes
the role, duty, and authority of the 3. Budget submission and approval process. The legal
Deputy Director
3.2.2.1 – The legal instrument framework may describe how proposed budgets are to
describes limitations on authority be submitted and approved, e.g., through the Ministry of
3.2.3 – The legal instrument Health or working directly through the Ministry of Finance.
establishes professional qualifications
or other competencies for the NPHI
Deputy Director 4. Bank accounts. The NPHI may be required to keep its
3.3 – The legal instrument establishes funds in the national bank or may be given the flexibility to
the role of technical or administrative
department leads– Details would depend use any reputable bank. The legal framework may specify
on the way the NPHI is organized. that the NPHI can keep and use its interest income.
3.3.1 – The legal instrument establishes
the position of Director for each of the
Departments of the NPHI 5. Use of funds. The legal framework may describe how
3.3.1.1 – The legal instrument funds can be used. For instance, specific language may
describes processes for appointment, be seen authorizing use of funds for purchasing supplies
resignation, or removal or addresses
tenure and equipment; paying staff salaries and other benefits;
3.3.1.2 – The legal instrument supporting staff secondment and transfers; purchasing,
describes the role, duty, and leasing, selling and/or renovating facilities; entering into
authority of the Director
3.3.1.2.1 – The legal instrument contracts; and making awards to recipients; among others.
describes limitations on authority of
the Director VII. Effective Date
3.3.1.3 – The legal instrument
establishes professional Depending on the country’s processes for formalizing legal
qualifications or other competencies
documents, language may be included about processes
for this position
required prior to the legal framework entering into effect,
for example, publication in a specific national government

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document. In addition, the authorization may be indefinite or
Fig. 5 – Legal domain and attributes for a certain number of years.
related to oversight and advisory boards

Domain 4: The legal instrument VIII. Repeal, Amendment, or Transfer of Prior


establishes NPHI oversight or advisory
boards
Authorities
Because NPHIs are often built on pre-existing organizations,
4.1 – The legal instrument establishes a
board of directors
there may be legislation, rules, or regulations that conflict
4.1.1 – The legal instrument articulates with the new legal framework. These may need to be
a role or purpose for the board repealed or modified. Language included in the legal
4.1.1.1 – The legal instrument
designates oversight functions
framework can cover such issues as:
4.1.1.1.1 – The legal instrument
provides the board with 1. Transfer of rights, obligations, and resources from a pre-
authority to approve budgets or
budget proposals
existing organization. For example, staff being transferred
4.1.1.1.2 – The legal instrument from a pre-existing organization may be required to
provides powers to the board sign employment contracts with the NPHI and complete
related to NPHI leadership
positions
orientations or training required by the new organization.
4.1.2 – The legal instrument sets
guidelines for the composition of 2. Repeal of provisions from previous legal documents.
boards
4.1.2.1 – The legal instrument
If specific authorities provided to the NPHI were explicitly
identifies sectors for mandated part of the legal mandate of another organization,
representation on the board changes must be made to harmonize the previous legal
4.1.2.2 – Representation from
various Ministries, e.g., Ministry
mandate with that of the NPHI. If the NPHI is being
of Agriculture or Education, is created as a parastatal and employees will not be under
mandated civil service, language should be included that makes this
4.1.2.3 – Representation from law
enforcement is mandated
change explicit.
4.1.2.4 – Representation from the
academic sector is mandated
4.1.2.5 – Representation from the
private sector and/or civil society is
mandated
4.1.3 – The legal instrument stipulates
how the board’s membership is
determined
4.1.3.1 – The legal instrument
describes how board members
are to be selected or designates
authority for determining

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nomination and selection of 5.1.2 – The legal instrument specifies


members to an entity content that is to be reported
4.1.3.2 – The legal instrument sets 5.1.2.1 – The legal instrument
board member tenure requires regular updates from
4.1.4 – The legal instrument establishes departments or from programs
parameters for the board operation 5.1.2.2 – The legal instrument
and conduct of business requires reporting of financial
4.1.4.1 – The legal instrument expenditures
establishes Board convening 5.1.2.3 – The legal instrument
periodicity requires reporting of significant
4.1.4.2 – The legal instrument research findings
recognizes or creates requirements 5.1.2.4 – The legal instrument
related to decision making, mandates reporting of population-
recording keeping, or public level health data
engagement 5.1.2.5 – The legal instrument
4.2 – The legal instrument enables other mandates development of and
boards or bodies (e.g., institutional review reporting on health indicators
boards, scientific advisory boards, etc.)
4.2.1 – The legal instrument specifies
the function of other boards
Fig. 7 – Legal domain and attributes for
4.2.1.1 – The legal instrument grants
authorization of resources (financial and
oversight functions
human)
4.2.1.2 – The legal instrument
grants advisory functions
Domain 6: The legal instrument
4.2.2 – The legal instrument makes
authorizes resources
provisions related to the makeup of the
board and/or the selection and tenure
6.1 – The legal instrument authorizes
of its members
funding for NPHI activities
4.2.3 – The legal instrument makes
6.1.1 – The legal instrument establishes
provisions related to the conduct of
an authorized funding ceiling
business of other boards or bodies
(maximum amount)
6.1.2 – Funding authorizations are time
bound
Fig. 6 – Legal domain and attributes for 6.1.3 – The legal instrument specifies
accountability reporting financial data that are to be reported
6.2 – The legal instrument designates
Domain 5: The legal instrument allowable sources of funding
establishes reporting mechanisms 6.2.1 – The legal instrument authorizes
appropriations from the state’s budget
5.1 – The legal instrument establishes 6.2.2 – The legal instrument authorizes
reporting mechanisms the receipt of gifts
5.1.1 – The legal instrument requires 6.2.2.1 – The legal instrument
reporting on a regular recurring basis designates prohibited sources of
5.1.1.1 – The legal instrument gift funds
requires annual reporting 6.2.3 – The legal instrument

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establishes a mechanism or NPHI to make financial awards to other


mechanisms for the collection of fees parties
6.2.4 – The legal instrument authorizes 6.7 – The legal instrument contains
receipt of development aid or awards restrictions on the use of funds
from foreign entities
6.3 – The legal instrument allows for
collection and use of income earned from
Fig. 8 – Legal domain and attributes
interest
related to the effective date and period of
6.4 – The legal instrument establishes
authorization
certain financial management
requirements
Domain 7: The legal instrument
6.4.1 – The legal instrument establishes
establishes an effective date
financial accounting requirements
6.4.2 – The legal instrument requires
7.1 – The legal instrument states when the
use of certain banks
authorizations contained within it goes
6.5 – The legal instrument sets
into effect
parameters for budget development and
7.1.1 – The legal instrument states a
submission
specific date
6.6 – The legal instrument authorizes how
7.1.2 – The legal instrument links the
funds can be used
effective date to an action (e.g. 180
6.6.1 – The legal instrument allows
days after enactment)
for funds to be used to purchase
7.2 – The legal instrument sets an
equipment and supplies
expiration date for authorities contained
6.6.2 – The legal instrument allows
therein
for funds to be used to purchase
commodities
6.6.3 – The legal instrument allows for
funds to be used to pay salaries and/or
other benefits
6.6.3.1 – The legal instrument
allows for funds to be used to cover
transfer of staff
6.6.3.2 – The legal instrument
allows for funds to be used to hire
new staff
6.6.3.3 – The legal instrument
allows for use of funds to cover
costs associated with seconded
staff
6.6.4 – The legal instrument allows for
funds to be used to lease, purchase or
renovate real property
6.6.5 – The legal instrument allows the
NPHI to enter into contracts
6.6.6 – The legal instrument allows the

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APPENDIX B. STEPS FOR CREATING A LEGAL
FRAMEWORK FOR AN NPHI
To develop and gain approval of a sound legal framework
for an NPHI requires a thoughtful process and considerable
investment of time and technical resources. If the legal
framework is being crafted at the same time the NPHI is being
created, the steps listed in Appendix C of the Africa CDC’s
document “Framework for Development of National Public
Health Agencies in Africa” are also an important reference.

Creating a legal framework for an NPHI requires support


at the highest levels in order to ensure that resources are
available to develop drafts and hold needed meetings,
to gain support from stakeholders, and to shepherd the
needed documents through the process required for high-
level government approval. Typically, the commitment of
the Minister of Health and often the President are critical to
successfully completing the legal framework.

The process for creating a legal framework for an NPHI is


often iterative, providing repeated opportunities for input
and modification. The following provides an outline of
some of the steps that may help to ensure a successful
outcome, that is, a well-crafted, widely accepted legal
framework for the NPHI. Some of these steps are one-time
activities; others will need to be repeated or implemented
continuously. The timing and sequencing of steps will vary
by country.

Identify leadership and staff support for developing the


legal framework
A senior person or group of people who have the respect
of key participants and technical and managerial skills
should be identified to lead establishment of the legal

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APPENDICES
framework. This person will help maintain the momentum
to complete the process, ensure a quality document is
created, and build support from stakeholders in and outside
of government. Besides the person who will lead the effort,
assistance is likely to be needed from a range of people
with different skills and experiences.

Develop a plan for establishing the legal framework


Part of the initial planning process for establishing the
legal framework for an NPHI should include laying out the
critical steps (many of which are described below) and
actions, including a timeline and identification of who will
be responsible for each activity. Such a plan can be used
for communications purposes, to measure progress, and to
ensure critical steps aren’t left out.

An early activity in the planning is researching the required


legal process, including approvals needed, supporting
documentation, and the sequence and expected timing for
obtaining the required approvals. Existing laws that may be
relevant to the legal framework must be identified to ensure
that any potential conflicts are identified and taken into
consideration.

As progress is made towards creating and gaining


support for the legal framework, the plans, timelines, and
responsible individuals may need to be updated.

Involve stakeholders early and often


This step includes mapping of key stakeholders whose
cooperation and support will be important to developing
and gaining approval of the legal framework. Stakeholders
include both individuals inside the Ministry of Health and

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APPENDICES
other parts of government that will be impacted by legal
establishment of the NPHI, as well as outside partners and
other organizations. Involvement of influential partners
such as the WHO may be helpful.

Stakeholder engagement is an ongoing process and


should include communication and coordination to increase
awareness of and support for the legal framework. Plans
for regularly communicating about changes that will be
happening, learning from the perspectives and experiences
of others, and incorporating stakeholder ideas and
concerns are important.

Determine the preferred NPHI governance structure


An important issue is whether the NPHI is a line agency,
reporting to the Minister of Health, or exists as a parastatal,
or has aspects of both. Some issues related to these
decisions are discussed in the IANPHI Best Practices Series
document: “Legal Mandates and Governance for NPHIs”
(http://www.ianphi.org/_includes/documents/Legislation%20
BP%20Guidance%20%20.pdf).

If the organization has oversight from a Board of Directors,


the composition and terms of that Board and other aspects
related to its functioning are often included in the legal
document. In some cases, the NPHI is established as a line
agency, since sometimes that can be done more quickly; in
some countries, an NPHI is first established as a line agency
while a legal framework creating a parastatal organization is
being developed.

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APPENDICES
Clarify the approval mechanism for establishing the legal
framework
The appropriate legal authority (or legal authorities) for
establishing the legal framework is different in different
countries, and also may differ based on whether or not the
NPHI will be a line agency in the Ministry of Health. In some
cases, the legal framework for the NPHI will be established
through legislation, in some cases through executive order,
and in some cases through some kind of administrative
rulemaking or regulation. Where there are options for
establishing the legal framework, factors such as speed,
flexibility, and long-term stability may support one approach
over another.

Identify legal documents that will need to be revoked or


changed when the NPHI is established
It is important to assess whether existing legislation,
decrees, rules, regulations, etc. potentially overlap or
conflict with the proposed legal framework. For example,
if the functions being assigned to the NPHI are currently
legally assigned to the Ministry of Health, the relevant
existing legal frameworks needs to be modified. If the NPHI
is being given new responsibilities related to One Health
or International Health Regulations, legal documents in
the departments that address issues related to animal
health, agriculture, or environmental health will need to be
reviewed and perhaps modified.

If people, property, and material goods that are currently


assigned to one organization are to be transferred, this may
need to be addressed formally. If NPHIs are responsible
for outbreak and emergency response, government rules
related to confidentiality of information about individuals
(e.g., patient records) and sharing of specimens, including

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APPENDICES
internationally, may also need to be assessed. Existing
legal documents may also need to be changed to ensure
the NPHI can fulfill international obligations, for example,
related to the International Health Regulations.

Determine what additional rules and regulations will


be required to further define the NPHI’s functions and
operations
Often, the legal framework document that establishes the
NPHI is relatively brief. Many additional rules and other
legally binding documents may be needed to provide the
detail about what the NPHI will do and how it will function.
The NPHI’s activities may also be informed by other
legislation or decrees not specifically designed for the NPHI,
for example, laws that impact food safety or laws designed to
address government-wide issues in emergency response.

Draft the legal framework


Once the appropriate research is completed and input
received, a legal framework can be drafted. Examples of
legal frameworks from a number of African countries are
included in Appendix C of this framework and at http://www.
ianphi.org/resources/toolkit/nphilegislation.html.

Provide opportunities for review of the drafts of the


documents that comprise the legal framework
The early and final draft(s) of the legal document(s) essential
to establishing the legal framework should be reviewed
widely internally and by a range of stakeholders, since once
it is legally binding, changes will be difficult. Stakeholder
engagement sessions may be a useful way of ensuring that
these documents reflect the priorities and are responsive
to the needs and interests of a wide range of stakeholder

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APPENDICES
groups and may ensure acceptance of and support for the
resulting legal framework.

Complete other steps or processes required for rule-making


In some countries, especially if a parastatal organization is
being formed, there may be a requirement for a business case
to be developed. Often proposed rules need to go through a
series of formal announcements and comment periods.

Conduct the remaining steps to achieve approval


Once the legal document(s) needed to establish the legal
framework are in final form they will need to be submitted
to the relevant authorities for approval. In addition, steps
should be taken to ensure successful implementation of the
legal framework. This may include assessment of additional
standards of practice, policies, or guides to assist with NPHI
functionality, as well as an assessment of any additional
legal authorities necessary to ensure NPHI functionality.

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APPENDICES
APPENDIX C. CASE STUDIES OF CREATING LEGAL
FRAMEWORKS FOR NPHIS, AND THE RESULTANT
LAWS, STATUTES, DECREES, OR REGULATIONS

C1. Guinea-Bissau Case Study, Decree-Law, and Statutes

Appendix C. Case Studies of Creating Legal


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Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
CASE STUDY
Case Series on Providing a Legal National Public Health Institute of Guinea Bissau
Framework for a National Public (INASA)
Health Institute: Guinea Bissau’s National Public Health Institute (INASA) was
The Guinea Bissau Experience formally established on August 26, 2010. The creation of
INASA was the culmination of over a decade of effort that
had been interrupted by war and political shifts.

Critical Aspects of the INASA Decree-Law and


Statutes
INASA is defined as having its own juridical personality
– it is financially, technically, legally, and administratively
autonomous. It is governed by a General Council, a
collective body that has authority to approve INASA’s
annual plans, accounts, budget, and activity reports. It
“works under the tutelage of the Ministry of Health.”

INASA has “patrimonial autonomy,” which means it controls


its property. For example, it can create regional centers. The
President of INASA is named by the Council of Ministers, in
response to a proposal by the Minister of Health. The only
stated requirement is that the President have a doctorate in
medicine or a related field.

Financial resources come from three major sources:


appropriations from the state budget, revenues from
services, and donations and grants from other institutions.
Among INASA’s responsibilities are developing a national
research agenda and conducting research, providing
recommendations for prevention measures to the Ministry
of Health, providing laboratory reference services, and
workforce training.

Legal Mechanism Used


INASA was established by Decree-Law No.12/2010,
passed by the Cabinet Council and signed into law by the

Appendix C. Case Studies of Creating Legal


PAGE | 37
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
President. The statutes of INASA describe key aspects of
CASE STUDY
the organization, such as its functions and governance.
These went into effect with passage of the Decree-Law and
publication in the Official Bulletin of Guinea Bissau.

Lessons Learned in Creating the Decree-Law


• High-level political support was critical for INASA’s
formation. The frequent turnover of Ministers delayed
INASA’s creation for many years.
• INASA was created by merging several pre-existing and
fragmented groups and functions, not all of which had
been in the Ministry of Health. Developing a plan that
would achieve the desired outcomes and addressed
the resistance to INASA among some parties required
extensive negotiation and hard work. For example, the
National School of Public Health, which trained public
health workers, midwives, laboratory technicians, and
other public health workers, had been under the Ministry
of Education. Although it became part of INASA, many of
its existing ways of operating were left intact.
• The support of other NPHIs in developing INASA was
critical. Having a Lusophone NPHI – Fiocruz – involved
was particularly helpful. Fiocruz and Mozambique’s INS
helped develop the first strategic plan and the statutes of
INASA, respectively.
• While the President of INASA is appointed by the Council
of Ministers for a term of five years, the basis under
which the President can be removed is not stated, which
means that decisions can be made to change leaders on
political or other grounds.

We thank Drs. Augusto Paulo Silva and Amabelia Rodrigues


for their assistance in developing this case study. Dr. Silva
had been Secretary of State/Deputy Minister of Health in
Guinea Bissau and a long-time champion of creating an
NPHI, and Dr. Rodrigues was the first President of INASA.

Appendix C. Case Studies of Creating Legal


PAGE | 38
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
NATIONAL INSTITUTE OF PUBLIC HEALTH (INASA)

CHAPTER I
NATURE, TASKS AND COMPETENCIES

ARTICLE 1
(Definition)

1. The National Institute of Public Health hereinafter referred to as INASA, is a


scientific institution of planning and implementation of the National Health
Policy and the National Policy for Education in the health sector.
2. INASA is an institution with its own juridical personality, endowed with
technical, administrative, financial and patrimonial autonomy, with
headquarters in Bissau, being able to create regional centres under its
dependence.
3. INASA works under the tutelage of the Ministry of Health
4. The following constitute financial resources of the National Institute of public
health:
a) Budget appropriations from the State Budget, pursuant to article 41 of the
decree establishing it;
b) Revenues generated by its own services;
c) Donations and grants from personalities or foreign, national or international
institutions;

ARTICLE 2
(Attributions)
INASA general attributions are:

a) Coordinate and oversee the definition of National Research Agenda for health
and implementation throughout the national territory;
b) Carry out scientific research on the health issues that contribute to the
reduction of morbidity and mortality of the population and disseminate their
results;
c) Recommend to the MoH prevention measures for disease control relevant to
public health, measures to be met by the public, private and community
sector;
d) Provide laboratory reference services to the National Health Service programs
in the prevention and control of communicable and non-communicable
diseases;
e) provide scientific and technical training in the areas under its competence;
f) contribute to the development and evaluation of programs and appropriate
technologies relevant to public health;
g) based on agreements of collaboration with the Directorates-General of the
MoH, particularly with the Directorate-General for Prevention and Health
promotion, carry out studies concerning the evaluation of health programs,
proposing eventual revisions and improvements for decision-making;
h) Encourage multidisciplinary and multi-sectoral research activities and promote
the strengthening of the national research capacity in health sciences.
i) Provide qualified advice and consultancy to the programs of prevention and
control of diseases, to normative and technical bodies of INASA management;
j) Develop epidemiological research, clinical, health services and in biological and
social sciences applied to the health of the mother and child;
k) Promote research, teaching activities and technical cooperation and
technological development aimed at the preservation of the environment;
l) participate in the formulation and implementation of National Health Policy
and the National Policy for education in the area of health
m) Propose communication strategies for health in collaboration with other
health-promoting institutions

Article 3
(Goals)
The objectives of INASA are namely:
a) Generate, absorb and disseminate scientific and technological knowledge in
health to provide strategic support to the national system of health and
contribute to the improvement of the quality of life of the population and for
the full exercise of citizenship;
b) Promote and carry out health research under the basis of the priorities set by
the National Research Agenda;
c) Encourage research in health system as an instrument for the definition of
health policy
d) Form and train human resources for health, science and technology;
e) Ensure the multisectoral and multidisciplinary scientific research, through
related research institutions and other bodies of recognized technical
competence

Article 4
(Competence)

For the fulfillment of its tasks, it is up to INASA to:

a) Investment of interest to carry out the prevention and control of diseases


relevant to public health, including communicable and non-communicable
diseases;
b) Develop, standardize or assess technologies applied to prevention and disease
control;
c) Serve as a reference laboratory to programs for disease control and
prevention, including the obligatory notification in public and private
institutions;
d) Implement studies in partnership with other national and international
institutions, about problems of common interest in public health and develop
reference laboratory functions;
e) Carry out Intra-and extra-mural activities of scientific and technical training,
postgraduate, to levels of higher and average technical and professional
education and participate in undergraduate training of mid-level and higher
levels of education in training institutions;
f) Promote e coordinate national development activities of research in health
science, particularly through institutional strengthening and scientific
upgrading of national technicians;
g) Coordinate with national and international scientific institutions, as well as
international agencies for development support in order to promote
technological transfer of knowledge, training and the upgrading of national
researchers and technicians;
h) Edit the magazine and the Guinean health collection and organize health visits
and other actions aimed at the production and dissemination of scientific
information.
i) Facilitate access by health professionals and the public in general to scientific
and technical information across the Organization and development of
specialized services.

CHAPTER II
Organic System
Section I
Structures

Article 5
(Bodies)

INASA has the following structure:

a) General Council
b) Board of Trustees
c) President of INASA
d) Scientific Council
e) Supervisory Board
Section II
COMPETENCE AND FUNCTION OF INASA’s STRUCTURES

Subsection I
Article 6
(General Council)

1. The General Council of INASA is a collective body with deliberating powers on


INASA general policy;
2. The General Council is composed of the:
a) President of the General Council
b) President of INASA;
c) President of the Scientific Council;
d) Director of the Centre for Management and Institutional Development;
e) Director of the Centre for Epidemiology and Community Health (Bandim
Health Project);
f) Director of the National Laboratory of Public Health;
g) Director of the Centre for Tropical Medicine;
h) Director of the Centre for Information and Communication for health;
i) Director for the National Health School;
j) Representative of Universities in the country;
k) Representative of the National Studies and Research Institute
l) Representative of the National Institute for Education Development;
m) Representative of the National Institute of Statistics;
n) Representative of the National Biodiversity Institute;
o) Representative of the National Institute of Agricultural Research;
p) Representative of the National of Applied Technological Research;
q) Representative of the Centre of Applied Fishing Research;
r) Representative of the Youth Institute;
s) Representative of the Institute of Women and Child;
t) Coordinator of Communicable Diseases Program;
u) Coordinator of Mother and Child Health Program;
v) Coordinator of the Environmental Health and Non Communicable Diseases;
w) Coordinator of Health System Development Program

3. The coordinators listed in subparagraphs t, u, v, and w are the INASA.


4. The president of General Council will be a Ministry of Health Staff preferably
technician in the health area, appointed by decree of the Minister of Health,
for a period of 3 years.
5. The general council meets in regular session twice a year and extraordinarily
walk by its chairman, or the chairman of INASA, with at least half of its
members.
6. The deliberations of the General Council are taken by consensus or, where that
is not possible, by an absolute majority of the members present.
7. Members of the Executive Board participate in discussion and voting, except
when it comes to voting on proposals submitted by the governing council to
the General Council.

Article 7
(General Council Functions)

Are the functions of General Council:

a) Consider and approve annual plans and program of INASA;


b) Approve annual accounts and activities reports;
c) Consider and approve annual budget of INASA;
d) Require external evaluation of the institution and pin down its goals;
e) Decide on changes in organic structure, according to the development and
needs of the institution, and consider the proposals for the creation of
research units and assigning labotorial reference functions.
f) Consider and approve the regulation of professional careers and the staff
establishment of INASA;
g) Elect, upon proposal of the President, the Chairman of the Supervisory Board;

Article 8
(President of General Council)

The President of the General Council shall inform, whenever necessary, the Ministry of
Health about the general situation of INASA and to this effect, presenting it the
program, plan, budget and annual accounts report, approved by the general council,
and other information deemed important for better oversight by the ministry.
Subsection II
Article 9
(Governing Board)

1. The Governing Board of INASA is composed of:


a. President of INASA;
b. President of Scientific Council;
c. Director of Central Management and Institutional Development;
d. Director of Center of Tropical Medicine;
e. Director of Center of Epidemiology and Community Health/PSB
(Bandim Health Project);
f. Director of National Public Health Laboratory;
g. Director of Health Information and Communication for Health;
h. Director of National Health School.

2. At the discussion and approval of the Governing Board program, annual


plan and budget, it will take part, the National Public Health Laboratory,
The Centre for Tropical Medicine, The School of Health and the National
Center of Epidemiology and Community Health/PSB.

Article 10
(Competence)

Is the competence of the Governing Board of INASA, under the direction of President:

a. Preparing the program, the annual plan and budget and the annual
accounts and activities reports and present them to the General
Council for discussion and approval;
b. Decide on the signing of agreements and protocols of cooperation
with other national and international organizations.
Article 11
(Appointment of Direction)

1. President of INASA is named in the Cabinet Council on a proposal by the


Minister of Public Health, among doctorates in medicine or related fields.

2. The remaining board members are appointed by the Minister of Public


Health, at the proposal of the President INASA by a hazard of five years.

Subsection III
Article 12
(Competence of President of INASA)

1. The President of INASA is the governing body of the institute, being


responsible for the direction and coordination of all activities of institution.

2. Also incumbent upon the President INASA:

a. Preparing the proposal of the program, annual plan and budget and
present it to the Governing Board;
b. Exercise disciplinary authority over all personnel of INASA;
c. Propose to the General Council changes to the organizational
structure of INASA;
d. Perform all other duties not covered in the competencies of other
organs, namely the General Board and the Supervisory Board.

3. For the preparation of the program, annual plan and budget, the President
of INASA prompts a mini-program plan and budget for each of the
following units:

a. National Public Health Laboratory;


b. Center of Tropical Medicine;
c. National Health School;
d. Center of Management and Institutional Development;
e. Centre of Epidemiology and Community Health;
f. Center for Information and Communication for Health.
Subsection IV
Article 13
(Competence of Scientific Council)

1. The President of the Scientific Council, directs and coordinates the scientific
activities of the Ethics Committee of the Centers and Research Units and
Service Units.

2. The Scientific Council comprises de following services:


a. Coordination of Communicable Diseases;
b. Coordination of Environmental Health and Non-Communicable
Diseases;
c. Coordination of Health Systems;
d. Centre of Epidemiology and Community Health / PSB;
e. Center for Tropical Medicine;
f. National School of Health;
g. National Laboratory of Public Health;
h. Center of Management and Institutional Development.

3. Is the competence of Scientific Council:

a. Appreciate, reviewing and monitoring protocols for scientific


research;
b. Promote opportunities for the discussion of research results and
technical-scientific subjects;
c. Appreciate technical and scientific development and staff training
programs;
d. Appreciate technical and scientific cooperation programs with
national and foreign institutions;
e. Organize Days of Health and other similar events.
4. The INASA exercise even through the Scientific Council, a power of
superintendence over the following technical and scientific units, as part of
its program and plan

a) Center of Epidemiology and Community Health ( Bandim Health Project)


b) Nacional Laboratory of Public Health ( Laboratorio Nacional de Saude Publica)
c) Center of Tropical Medicine
d) Center of Information and Communication in Health
e) Center of Management and Institutional Development

Subsection V
Article 15
Financial Council

The financial department composed of President, Vice-President, Secretary, assistant


secretary and two other members.

Article 16
(Competency)

1. Responsibilities of Financial Department


a) Appreciate the functionality of financial management
b) Check the budget of expenses
c) Dispatch the report about expenses and activities to Main Department
2. On any occasion requests, will be given to the supervisory board details about
the financial management, access to books or any accounting records.

Chapter III
Advisory and technical bodies

Article 17
INASA consists of adviser organ, the National Ethics Committee for Health
Article 18
( Ethic Committee)

The National Ethics Committee for Health responsibilities:

a) Encourage researchers for biomedical field and the general public about the
principles and values that command research on humans and animals, as well
the nature of ethical problems that are attached to them also the solutions
that must be considered.
b) Judge on proposed research protocols for their researchers to ensure the
protection of communities, humans and even animals for experimentation
when subjected to biomedical research or other.
c) Cooperate with the National Bioethics Committee for Health in their activities.

Article 19
(Independence and functionality)

The Ethics Commission is independent in its deliberations, and its composition and
functioning in own fixed rules proposed by the scientific council and approved by the
governing board.

Chapter IV
(Final Provisions)

Article 20

INASA will developed and submitted to the approval of the ministry of health, within
six months after the promulgation of this Diploma, rules of their organs.

Article 21
(Subsidiary rules)
The doubts arising in interpretation, and the application of this statute shall be
resolved by order of the minister of health.
Article 22
(Transitional provision)

While the National Research Council for Health and the National Council of bioethics
are being created, their functions and tasks will be ensured by INASA.
APPENDICES
APPENDIX C. CASE STUDIES OF CREATING LEGAL
FRAMEWORKS FOR NPHIS, AND THE RESULTANT
LAWS, STATUTES, DECREES, OR REGULATIONS

C2. Liberia Case Study and Law

Appendix C. Case Studies of Creating Legal


PAGE | 50
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
CASE STUDY

Case Series on Providing a Legal National Public Health Institute of Liberia (NPHIL)
Framework for a National Public The National Public Health Institute of Liberia (NPHIL) was
Health Institute: officially established by the NPHI Act of 2016, which was
The Liberia Experience signed into law by the President in January 2017. This law
was passed quickly, to address the weaknesses in public
health observed during Liberia’s response to the 2014-2015
Ebola outbreak. The process used to develop the law and
its content and garner support is described in the IANPHI
“Case Study: Creating the National Public Health Institute
of Liberia” (http://www.ianphi.org/_includes/documents/
Legislation%20BP%20Case%20Study_Liberia%20.pdf).

Critical Aspects of the NPHI Act to Establish NPHIL


The Act establishes NPHIL as a “corporate body with
perpetual existence and a common seal.” NPHIL may
conduct business and has responsibilities similar to how
other corporations operate. It is governed by a Board
of Directors, which includes Ministers of Heath, Finance
and Development Planning, Justice, and Agriculture; the
University of Liberia; and six non-statutory members. The
Board functions, tenure of members, requirements for
meetings, and other aspects of Board functioning are
included in the Act.
The law specifies the functions of the NPHIL, some of
which derive from transferring public health and biomedical
research functions, property, and staff from the Ministry
of Health to NPHIL. It includes provisions related to
both communicable diseases and non-communicable
conditions, e.g., injuries. The role of the Minister is defined
to include policies and practices related to the health
sector, formulation of policies related to public health, and
recommending an annual research agenda for Liberia’s
health priorities to NPHIL. Requirements, functions, and
terms of the Director General and two Deputy Directors
General are also specified, as are issues related to

Appendix C. Case Studies of Creating Legal


PAGE | 51
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
financing and budget.
CASE STUDY
By establishing the NPHIL as a parastatal organization
rather than a line agency, NPHIL will have the autonomy
needed to respond quickly to public health emergencies.

Legal Mechanism Used


NPHIL was formally established by a law. With support from
the Minister of Health and the President, the legal drafting
and approval process took only a little over a year.

Lessons Learned in Creating the Law


• In Liberia, the support of the President and other high-
level officials was important for creating a parastatal
agency and also sped what is usually a time-consuming
process.
• Two factors that facilitated passage of the Act were
the sense of urgency following the Ebola crisis and
that other changes to the law governing the Ministry
of Health were being made at the same time, e.g.,
transferring the Department of Social Welfare to a newly
created ministry.
• The involvement of influential partners, like WHO, US
CDC, and IANPHI, was helpful. A step-wise approach,
with extensive stakeholder involvement, including from
legislators, helped ensure buy-in. Some issues, such as
moving research and the reference lab to the NPHIL,
were contentious and required extensive discussion.
• NPHIL started to function as an NPHI before the law
was passed, providing an early demonstration of its
usefulness.
• Based on his experience, Dr. Nyenswah encourages all
countries in Africa to create NPHIs. He suggests that
Africa CDC, WHO, and US CDC speak with one voice to
affirm the importance of establishing NPHIs.
We thank Dr. Tolbert Nyenswah, Director of NPHIL, for his
assistance in developing this case study.

Appendix C. Case Studies of Creating Legal


PAGE | 52
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
An Act to Establish the National Public Health Institute of
Liberia

AN ACT TO ESTABLISH THE NATIONAL PUBLIC


HEALTH INSTITUTE OF LIBERIA

REPUBLIC OF LIBERIA

0
AN ACT TO ESTABLISH THE NATIONAL PUBLIC HEALTH INSTITUTE OF LIBERIA

WHEREAS, the Legislature is authorized under Chapter 10, Article 89 of the 1986 Liberian
Constitution to enact legislations to create agencies and commissions of government as
may be necessary for the effective operation of the government;

WHEREAS, there have been profound insurgences of infectious diseases which threatened
the life of all the people of Liberia as evidenced by the recent unprecedented outbreak of
Ebola Virus Disease (EVD) in West Africa which exposed weaknesses in Liberia’s national
health care system and highlighted the need for the establishment of a public health
institution in Liberia to support national health delivery services;

WHEREAS, it has now become incumbent upon Liberia as a nation to create an institution
to collaborate with and strengthen the Ministry and other Institutions in the Health Sector
to heighten the infection prevention and control efforts of the of the Government of
Liberia;

Now therefore it is hereby enacted by the Senate and House of Representatives of the
Republic of Liberia, in Legislature assembled:

PART I: PRELIMINARY PROVISIONS

Section 1.1: Short Title

This Act shall be cited as “the NPHI ACT OF 2016.”

Section 1.2: Repeal and Amendment

Immediately upon the passage of this Act:

a. “The act establishing the National Research Institute of Liberia (commonly


known as Liberia institute for Biomedical Research (LIBR))” is hereby
repealed.

b. Section 30.2 (d, e, o) of the 1972 Executive Law, Title 12 of the Liberian Code
of Law revised is hereby amended transferring public health and biomedical
research functions of the Ministry of Health to NPHIL.

Section 1.3: Definitions

Unless otherwise stated in this Act, the following terms shall have meanings as follows:

1
a. “Abandonment of duty” as defined by the Decent Work Act of 2015
b. “Board” means the Board of Directors of NPHIL.
c. “Consulting and service fees” means fees earned for services provided by NPHIL.
d. “Conviction” means determination of guilty by a court of competent jurisdiction of
crimes related to fraud, bribery, perjury, misrepresentation, corruption, plagiarism
or other felonious crimes
e. “Deputy Director General” means the person appointed under Section of this Act.
f. Director General” means the administrative head of NPHIL appointed under Section
15 of this Act.
g. “Foundation” means an independent, fundraising body to be established by the
Board as referred to in Section 18.
h. “Grossly inefficient” as defined by the Decent Work Act of 2015
i. “Indirect costs/institutional charges” means a fixed percentage levied by NPHIL on
all research grants.
j. Institute” means the NPHIL
k. “Minister” means the Minister of Health.
l. “Ministry” means the Ministry of Health.
m. “NPHIL” means the National Public Health Institute of Liberia.
n. “ “Operational research” means non-medical research that supports logistical and
health management decisions
o. “Response” is the rapid, coordinated detection and control to outbreaks.
p. “Surveillance” epidemiological practice by which the spread of disease is monitored
in order to establish patterns of progression
q. “Intellectual property” means any property as defined by the Patent, Copyright and
Trademark Law of Liberia, Title 24

PART II: THE NATIONAL PUBLIC HEALTH INSTITUTE OF LIBERIA

Section 2.1: Establishment of the National Public Health Institute of Liberia

a. There is hereby established the National Public Health Institute of Liberia as a


corporate body with perpetual existence and a common seal. It may sue and be sued
in its own name and subject to the provision of this act; performs such other acts as
corporate bodies may lawfully perform.
b. The Institute shall be an autonomous agency of the government but for the sake of
proper coordination of the health services shall share scientific information reports
with and have sectorial reporting accountability to the Ministry of Health.
c. The Institute may in the performance of its function acquire and hold movable and
immovable property and may enter into contracts or any other transactions that a
state-owned enterprise may enter into.

2
Section 2.2: Composition

The NPHIL shall be comprised of following six departments:

a. Department of Training and Capacity Building


b. Department of Infectious Diseases and Epidemiology
c. Department of Laboratory and Public Health Diagnostics
d. Department of Environmental and Occupational Health
e. Department of Public Health and Medical Research and Development
f. Department of Administration

Section 2.3: Objective of the National Public Health Institute of Liberia

The overall objective of NPHIL is to improve the health status of the population of Liberia
in collaboration with relevant agencies and institutions of government. The specific
objectives are as follows:

a. Contribute to the development and sustainability of public health workforce


b. Develop, enhance, and expand the surveillance and response platforms
c. Develop and strengthen the laboratory system and public health diagnostics
d. Develop, enhance, and expand processes and structures to protect environmental
and occupational health
e. Expand, conduct, and coordinate public health and medical research to inform
Liberian public health policies

Section 2.4: Functions and Operation of the National Public Health Institute of Liberia

a. NPHIL shall perform the following:


i. coordinate, develop, and maintain surveillance systems to collect, analyze,
and interpret health data to guide health interventions;
ii. use surveillance data to advise on setting health policies, priorities, and
planning;
iii. use public health information for monitoring and evaluation of policies and
interventions;
iv. coordinate reference laboratory and laboratory referral services;
v. provide leadership and direction to counties and local authorities on disease
and injury surveillance and outbreak response;
vi. promote cooperation between Liberia and other countries with regard to the
epidemiological surveillance and management of diseases and injuries,
including strengthening cross border and regional public health efforts;
vii. strengthen capacity of the health workforce in health surveillance to reduce
the burden of disease and injury;

3
viii. strengthen epidemiology and surveillance of communicable and
non-communicable diseases;
ix. prevent diseases and workplace illnesses and injuries
x. promote environmental responsibility
xi. enforce environmental and public health laws, policies, and regulations
xii. advise the Minister on strategies to improve the health of the population;
xiii. support the health response and provide recommendations to government
on control measures for disease outbreaks and mitigating health risks and
hazards;
xiv. collaborate with relevant government departments and government
agencies to implement communication strategies on public health issues and
outbreak response;
xv. provide technical support to all spheres of government and other regulatory
bodies on disease surveillance, prevention, and control;
xvi. conduct research to inform policy and guidelines on public health and
develop processes for dissemination of research findings to key
stakeholders;
xvii. strengthen advocacy, social mobilization and partnerships related to public
health research;
xviii. provide training and technical information on health issues to health
professionals, government and regulatory bodies;
xix. maintain accredited reference and specialized laboratories for pathogen
detection, disease and injury surveillance and monitoring, outbreak response
and the provision of scientific evidence to prevent and control infectious
diseases;
xx. set up Institutional Review Board on public health and medical research
xxi. coordinate activities relevant to national specimen biobank
xxii. Recommend the quarantine and isolate of persons who have a communicable
disease constituting a public health threat
xxiii. Recommend the declaration of public health emergency and disease
outbreaks based on available public health data

b. NPHIL may:
i. liaise with any other regulatory authority or institution and exchange
information with and receive information from any such authority or
institution in respect of matters of common interest or public health concern;
ii. cooperate with persons and institutions undertaking basic research in
Liberia and in other countries by the exchange of scientific knowledge and
the provision of access to the resources and specimens available to NPHIL;
4
iii. Participate in joint research operations with government departments,
tertiary institutions, museums, scientific institutions and any other persons ;
iv. Produce and sell by-products.
v. Collaborate with the Ministry of Agriculture and other appropriate agencies
of Government in maintaining data and giving advice to Government on the
population dynamics of its wildlife reserves, their biotic interactions and
their socioeconomic, biomedical, and cultural significance, with the view of
protecting the reserves from indiscriminate removal or abuse in the context
of One Health.
vi. Perform such other functions as may from time to time be required by or
consented to by the Board.
vii. Promulgate and issue regulations governing NPHIL in the field of public
health research in Liberia.

PART III: GOVERNANCE AND CONTROL

Section 3.1: Role of the Minister

The Minister shall:

a. Continue to exercise the functions and responsibilities provided for in the Act
establishing the Ministry and the Public Health Law, except as altered by the
amendments identified in Section 1.3 of this Act.
b. Subject to the exercise of functions, powers and authority of the NPHIL pursuant to
this Act and other applicable laws, the Ministry shall undertake such functions and
responsibilities as are appropriate for the attainment of adequate, affordable and
accessible health care delivery system in Liberia, and in particular the Ministry shall
have the capacity and responsibility under this Act to:

1. provide policy advice to the Government of Liberia on matters relating to the


health sector on both domestic and international matters;

2. develop policy of general application to the health sector;

3. encourage and promote the provision and availability of quality, accessible


and affordable health services for the people of Liberia;

4. represent the health policy interests of Liberia in international health


organizations;

5
5. support the establishment of a regulatory environment that facilitates the
improvement of health services in Liberia; and

6. Take such other actions as are needed to co-ordinate Government policies


and programs affecting the health sector generally.

c. Have the authority to formulate policies related to public health.


d. Have the authority to recommend annual research agenda for Liberia’s health
priorities to NPHIL.

Section 3.2: Board of Directors


There is hereby established a Board of Directors which shall be the governing body of
NPHIL and which shall consist of eleven members. The Board shall be comprised of five (5)
statutory members and six (6) other members appointed by the President.

Section 3.3: Composition of the Board


The Board shall consist of:
a. The Minister of Health;
b. The Minister of Finance and Development Planning;
c. The Minister of Justice;
d. The Minister of Agriculture;
e. The University of Liberia; and
f. Six (6) other non-statutory members one of whom shall be the Chair who shall have
a minimum of a master’s degree in public health, public policy, medicine, health
administration, or research-related disciplines and a minimum of three years’ work
experience and must be a person of integrity.

Section 3.4: Functions of the Board

The Board shall:

a. Consider and approve annual plans and programs of NPHIL.


b. Vet and appoint the Deputy Director Generals and Directors of all Departments.
c. Vet and recommend at most three (3) persons for the position of the Director
General for appointment by the President.
d. Approve annual budgets, strategic and operational plans.
e. Ensure contracts, agreements, and memorandums of understanding with third
parties, contractors, and agencies are consistent with applicable laws.
f. Decide in changes in the organic structure of NPHIL according to the development
and needs of NPHIL.
6
g. Establish the NPHIL Foundation.
h. Receive and approve reports from the Director General on the progress of NPHIL.
i. Draft, adopt, and enforce bylaws for the Board.
j. Ensure the proper implementation of this Act.
k. Approve the salary structure of the Director General and the Deputy Director
General
Section 3.5: Tenure of the Board

a. The President will appoint the non-statutory members of the Board, and they will
serve for a term of three (3) years. All non-statutory Board members will be eligible
for re-appointment once.
b. Resignation, Suspension, Removal
i. Resignation
1. Any member of the Board may voluntarily resign by submitting a
letter of resignation to the President.
2. A member who has two unexcused absences within the period of
one year will be considered to have resigned his position on the
Board.
3. If a statutory member has two unexcused absences within the
period of one year, the Board will take appropriate action against
such statutory member.

ii. Suspension
No member of the Board of Directors shall be suspended except upon the
recommendation of a vote by two-thirds majority of the members of the
Board to the President, provided, however, that a Board Member shall
suspended for cause.

iii. Removal
A member of the Board shall be disqualified or removed if:
1. Convicted of any crimes by a competent tribunal consistent with due
process of law; or
2. The member is no longer able to perform the duties due to physical
or mental incapacity, as certified by at least two qualified medical
doctors or psychiatrists; or
3. It is discovered that a member has at any time been convicted of an
offense involving dishonesty, whether in Liberia or elsewhere; or
4. The member ceases to be a resident of Liberia.

7
Section 3.6: Board Meeting

a. Time of Meeting: The Board should meet at least once every three (3) months to
conduct business of the Institute.
b. Venue: The Board shall meet at a place that is designated by the Chairman, provided
that it is in Liberia.
c. Leadership: The Chairman of the Board shall preside at meetings. At the first ever
meeting of the Board, members of the Board shall elect a Vice Chairman, who will
preside in the absence of the Chairman.
d. Quorum: Simple majority of Board members present at a meeting of the Board shall
constitute a quorum, provided both statutory and non-statutory members are
present.
e. Decision: A vote of a simple majority present at a meeting shall be required for a
decision, except as to those decisions for which a two-thirds majority of members is
required by this Act.

Section 3.7: Committees of the Board

The Board may constitute external advisory group and relevant committees comprising of
members of the Board and technical experts from time to time as the need arises.

PART IV: THE DIRECTOR GENERAL AND DEPUTY DIRECTOR GENERALS

Section 4.1: Appointment of the Director General

The President shall, upon the recommendation of the Board of Directors, appoint the
Director General.

Section 4.2: Qualifications of the Director General

The Director General must have the following qualifications:


a. a minimum of a master’s degree in public health or a doctorate degree in biomedical
sciences
b. a minimum of five years of progressive technical work experience in a scientific or
public health research setting of which a minimum of 2 years of management
experience
c. a person of integrity
d. a demonstrated track record of successful grant applications

8
e. a minimum of five (5) public-health related, scientific publications in peer-reviewed
journals

4.3: Functions of the Director General

The Director General shall:

a. Be the administrative head of NPHIL and carry out the day-to-day functions of
NPHIL.
b. Report to the Board.
c. Appoint qualified, competent and suitable persons as employees below the rank of
Deputy Directors, pursuant to organizational structure of NPHIL.
d. Be responsible for delivering on the agreed mandate of NPHIL as determined by the
Board in the terms of this Act.
e. Formulate and develop internal rules and directives for an efficient and effective
administration of the institute.
f. effectively organize and maintain staffs
g. be responsible for effective placement of staffs Utilization of staffs and resources to
achieve maximum operational results.
h. Sign on behalf of the entity all memoranda of understanding, contracts, and
agreements with key stakeholders consistent with Public Procurement and
Concession Commission Act and all other applicable laws thereto.
i. be responsible for the issuance of guidelines in regards to the manner which claims
shall be handled
j. Advise the Ministry on health-related challenges in Liberia.
k. prepare the annual budgets, strategic and operational plans, and submit to the
Board for approval
l. serve as the Secretary of the Board
m. exercise all powers in conformance of any such duties as may be delegated or
assigned by the Board
n. ensure the proper implementation of this Act

4.5: Tenure of the Director General


The Director General shall serve for a term of five (5) years. He or she will be eligible for re-
appointment once.

i. Resignation

9
The Director General may voluntarily resign by submitting a letter of resignation
to the President, provided that he or she gives two months notices prior to the
date of his or her resignation.

ii. Suspension
The Director General shall be suspended for by the President for cause upon
the recommendation of a vote by two-thirds majority of the members of the
Board.

iii. Removal
The Director General shall be removed if:
1. Found to be grossly inefficient;
2. Found to be corrupt;
3. Convicted of any crime by a competent tribunal consistent with due
process of law; or
4. No longer able to perform the duties due to physical or mental
incapacity, as certified by a qualified psychiatrist or medical doctor;
or
5. It is discovered that a member has at any time been convicted of an
offense involving dishonesty, whether in Liberia or elsewhere, and
sentenced to imprisonment without the option of a fine; or
6. No longer a domicile in Liberia.

Section 4.5: Appointment of the Deputy Directors General


The Board shall appoint two Deputy Directors General, one for Technical Services and one
for Administration.

Section 4.6: Tenure of the Deputy Director Generals


The Deputy Directors General shall each serve for a term of four (4) years. They shall each
be eligible for re-appointment once.

4.7: Qualifications of the Deputy Director General of Technical Services

The Deputy Director General of Technical Services shall have the following qualifications:
a. a minimum of MD, PHD, DRPH with experience in in public health.
b. a minimum of five years’ work experience in a scientific or public health research
setting
10
c. a person of integrity
d. a demonstrated track record of grant applications
e. a minimum of 5 public-health related, scientific publications in peer-reviewed
journals

4.8: Qualifications of the Deputy Director General of Administration

The Deputy Director General of Administration must have the following qualifications:
a. a minimum of a master’s or advanced degree or its equivalent in business
administration, law or related disciplines
b. a minimum of five years’ work experience in a financial or administrative capacity
c. a person of integrity
d. a demonstrated track record in management of grants

4.9: Functions of the Deputy Director General for Technical Services


The Deputy Director General for Technical Services shall:
a. serve as chief scientist for the NPHIL
b. act in the absence of the Director General
c. report to the Director General
d. serve as supervisor for all technical or science departments pursuant to
organizational structure of NPHIL
e. be responsible for delivering on the agreed mandate of NPHIL as determined by the
Board in the terms of the technical aspects of this Act
f. perform all other functions as assigned by the Director General

Section 4.10: Functions of the Deputy Director General for Administration


The Deputy Director General for Administration shall:
a. act as Director General in the absence of both the Director General and Deputy
Director General of Technical Services
b. report to the Director General
c. serve as supervisor for the financial and administration departments pursuant to
organizational structure of NPHIL
d. be responsible for delivering on the agreed mandate of NPHIL as determined by the
Board in the terms of the administrative aspects of this Act
e. perform all other functions as assigned by the Director General

11
4.11: Resignation, Suspension and Removal of Deputy Directors General

a. Resignation
The Deputy Directors General may voluntarily resign by submitting a letter of
resignation to the Board.

b. Suspension
The Deputy Director Generals shall be suspended by a vote of two-thirds majority of
the members of the Board for cause.

c. Removal
A Deputy Director General shall be removed if:
1. Found to be grossly inefficient;
2. Found to be corrupt;
3. Convicted of any crime by a competent tribunal consistent with due
process of law; or
4. No longer able to perform duties due to physical or mental
incapacity as certified by at least two qualified medical doctors or
psychiatrists; or
5. It is discovered that a member has at any time been convicted of an
offense involving dishonesty, whether in Liberia or elsewhere, and
sentenced to imprisonment without the option of a fine; or
6. No longer a domicile in Liberia.

PART V: FINANCIAL PROVISIONS


Section 5.1: Funding
a. The NPHIL shall be funded through:
i. Budgetary allocation.
ii. Fees from sale of research products.
iii. Grants and donations.
iv. Indirect costs/institutional charges on all grants.
v. Consulting and services fees.
vi. Cooperative agreements with other governments.
vii. Intellectual property including patents.
viii. NPHIL Foundation,
ix. Investment and
x. any other lawful means

12
b. All funds to be generated by NPHIL as listed in a(i-viii) of this Section shall be
retained by NPHIL for the purpose of defraying its expenses.

Section 5.2: Annual Budget


a. The Director General shall prepare and submit to the Board for approval an annual
budget for the ensuing year which the Board shall approve and subsequently submit
to the Minister of Finance and Development Planning.

b. The budget must include details of NPHIL income and expenditure for the current
and two subsequent years including actual from the past year. The budget must
include detailed and comprehensive estimates of the current year’s known and
anticipated income and expenditure and a projection of income and expenditure for
the next financial year as well as the following year along with carried forward
balances or as required under the budget law.

Section 5.3: Procurement

The operation of the NPHIL shall be in accordance with the Public Procurement and
Concessions Commission Act, as amended and reinstated in 2010.

Section 5.4: Accounts and Audit

a. NPHIL shall keep up-to-date and accurate accounting and financial records, which
shall conform to laws, applicable statutes and regulations.

b. Subject to the Board’s approval, NPHIL will open and maintain accounts with the
Central Bank of Liberia and any other reputable local bank for purpose of carrying
out its affairs.
c. The Director General shall submit the account of NPHIL to the Board who shall from
time to time commission audit(s).

d. NPHIL is subject to the audit of the General Auditing Commission.

Section 5.5: Report

13
a. The Director General shall submit quarterly and annual report consisting of
financial and programmatic information to the Board for onward submission to the
President and to the Legislature.
b. The Director General shall submit other reports as may request by the Minister from
time to time on specific issues, programs, or periods.
c. The Director General is required to report to the Minister, President and Legislature
within a period of forty-eight hours significant findings from studies that may
inform or influence policy decisions.

PART VI: MISCELLANEOUS PROVISIONS


Section 6.1: Intellectual Property
Ownership of intellectual property generated by persons employed by NPHIL during the
course of their engagement with NPHIL shall vest in the Institute of the Republic of Liberia.

Section 6.2: Confidentiality

a. All patent related research information or findings, processes, research, techniques,


or plans shall be kept confidential, except as provided herein.
b. All information receive by the relevant parties herein shall be kept confidential

c. Members of the Board of Directors, the Director General, officers, employees, and
staffs of NPHIL shall treat all information obtained in the course of their
employment and/or engagement with NPHIL strictly confidential, not to be
disclosed to any third party, and shall not use it for any other purpose other than for
the purpose of this Act.

d. NPHIL shall ensure that its officers, employees, and all associates treat partners’
information as confidential.
Any breach of the above confidentiality provision shall be punishable according to law.

PART VII: TRANSITIONAL PROVISIONS

Section 7.1: Transfer of Property


As of the effective date of this Act, all properties and assets of the Emergency Operations
Center, National Reference Laboratory, and Disease Prevention and Control Unit of the
Ministry of Health, and the National Research Institute (also referred to as the Liberia

14
Institute for Biomedical Research), the Division of Environmental and Occupational Health
of the Ministry of Health, shall be transferred to the NPHIL.

Section 7.2: Transfer of Employees


a. As of the effective date of this Act, employees of the Emergency Operations Center,
National Reference Laboratory, and Disease Prevention and Control Unit of the
Ministry of Health, and the National Research Institute (also referred to as the
Liberia Institute for Biomedical Research), Division of Environmental and
Occupational Health Services of the Ministry of Health shall be transferred to NPHIL
subject to the Civil Service requirements.

b. Any person transferred to NPHIL shall:


i. Sign the Professional Ethics and Code of Conduct of NPHIL prior to assuming
duties or within thirty (30) working days after the effective date of the Act;
ii. Sign the Employee Handbook of NPHIL prior to assuming duties or within
thirty (30) working days after the effective date of the Act;
iii. Be subject to the Human Resource Management Manual of NPHIL, the
Professional Ethics and Code of Conduct of NPHIL and related regulations
and to the administration of NPHIL;
iv. No longer be a civil servant; and
v. Sign employment contracts with NPHIL in line with the Decent Work Act

c. All transfers relating to the commencement of the NPHIL shall be completed within
twelve (12) months as of the effective date of this Act.

ANY LAW TO THE CONTRARY NOTHWITHSTANDING

15
APPENDICES
APPENDIX C. CASE STUDIES OF CREATING LEGAL
FRAMEWORKS FOR NPHIS, AND THE RESULTANT
LAWS, STATUTES, DECREES, OR REGULATIONS

C3. Mozambique Case Study and Decree

Appendix C. Case Studies of Creating Legal


PAGE | 69
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
CASE STUDY

Case Series on Providing a Legal Mozambique National Institute of Health (INS)


Framework for a National Public The National Institute of Health of Mozambique (INS) was
Health Institute: established in 1976 as a division within the Preventive
The Mozambique Experience Medicine Directorate of the Ministry of Health (MoH). In
1983, the INS became a distinct institution within the MoH,
with limited autonomy. This changed in 2017, with the
passage of Decree 57/2017.

Critical Aspects of the new INS Legal Framework


The 2017 Decree provides the INS with autonomy and
assigns it additional public health responsibilities, while
also increasing its operational efficiency. For example, the
INS budget is now negotiated directly with the Ministry of
Finance. In addition, the INS is now authorized to establish
sub-national divisions. With more operational autonomy, INS
will be better able to rapidly respond to outbreaks, have
improved efficiency in conducting nation-wide surveys,
and have increased capacity for grant management and
oversight.
Under the Decree, the Director-General and Deputy
Director-General are appointed by the Prime Minister
for renewable terms of five years, which helps ensure
institutional stability. The INS must establish strong
collaboration and coordination with the MoH, as the INS is
technically supervised by the Minister of Health.
INS funding derives from a number of sources, but still
depends heavily on external funding through bilateral
or multilateral funding mechanisms, as well as through
competitive grants.

Legal Mechanism Used


The legal framework for the INS is the Decree passed by
the Council of Ministers and signed by the Prime Minister,
which is the approach used to establish public institutes in

Appendix C. Case Studies of Creating Legal


PAGE | 70
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
Mozambique. The Decree includes high-level parameters,
CASE STUDY
such as the INS mission, INS functions, and qualifications
and terms for leaders of the INS. Statutes passed by an
Inter-Ministerial Commission, chaired by the Prime Minister,
provide more detail, for example, about the functions of the
directorates.

Lessons Learned in Creating the Decree


• INS’ reputation and visibility were critical for garnering
support. The INS already had a solid national and
international reputation, due to its achievements in fields
such as research, surveillance, outbreak investigations,
reference laboratory services, and education.
• The support of the Minister of Health was essential for
the passage of the Decree.
• The INS had developed a strategic vision and was
working to achieve it before the Decree was passed.
(Fiocruz provided critical assistance in developing INS’
vision and plans.) INS leadership recognized that more
autonomy would help the INS to be a more nimble,
efficient organization. When the political situation was
favorable, the INS was poised to take advantage of the
opportunity to redefine itself; it had clearly articulated
plans and clear messages about how changing its status
would be good for public health.
• In developing its framework, the INS consulted with
NPHIs from around the world, Directorates within the
MoH, and other Ministries in Mozambique to ensure a
solid and robust organizational and functional structure,
as well as alignment with national legislations. For
example, consultation with the Ministry of Finance
was essential for budgetary issues, with the Ministry
of State Administration to ensure consistency of the
organizational structure with national legislation, and
with the Ministry of Science and Technology to ensure
alignment with national policies and strategies on
Science and Technology.
We thank Dr. Eduardo Samo Gudo Jr., Deputy Director-
General at INS, for his assistance in developing this case
study.

Appendix C. Case Studies of Creating Legal


PAGE | 71
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
Summary
Council of Ministers:
Decree No. 57/2017:
Redefines the nature, attribution, and competencies of the National Institute of Health in
order to intensify the coordination, management, and realization of health research.
Resolution No. 46/2017:
Approves the Social Action Policy and Implementation Strategy and revokes Resolution
No. 12/98 of April 9.

COUNCIL OF MINISTERS
Decree No. 57/2017
of November 2nd
There being the need to redefine the nature, attribution, and competencies of the
National Institute of Health to intensify the coordination, management, and realization of health
research, under provision 1 of article 82 of Law No. 7/2012, of February 8, the Council of
Ministers decrees:

Article 1 (Nature)
The National Institute of Health, abbreviated as (INS) is the entity for the management,
regulation, and oversight of activities related to the generation of scientific evidence in health to
guarantee better health and well-being, endowed with legal personality, with administrative and
technical-scientific autonomy.

Article 2 (Scope and Headquarters)


1. The INS has its headquarters in the Province of Maputo, in the District of Marracuene,
and carries out its activities throughout the national territory.
2. With the authorization of the Minister who oversees the health area, after hearing the
Minister who oversees the area of finance and the Provincial Government, the INS may create
and extinguish delegations or other forms of representation in any part of the national territory.

Article 3 (Guiding Principles)


Within the scope of its activities, INS is guided by the following specific principles:
a) Excellence and continuous self-evaluation;
b) Respect for human rights;
c) Respect for codes of ethics and professional deontology;
d) Transparency and accountability;
e) Promotion of participatory management and innovation capacity;
f) Universality and equity;
g) Collective solidarity;
h) Promotion of multi-sectoral and transdisciplinary exchange;
i) Appreciation of national professionals, as well as national biological and cultural
heritage.

Article 4 (Attributions)
The powers of the INS are:
a) Preparation of policy and strategy proposals in the area of health research,
ensuring their correct implementation, monitoring and periodic evaluation.
b) Promotion of the development of health research at different levels of care to
ensure a better definition of Health Policy and program management in order to
provide a timely and effective response to health problems.
c) Conducting clinical, biomedical, pharmacological, epidemiological, socio-
anthropological and health-related research, based on national priorities.
d) Contribution to the development, evaluation, and promotion of the use of
appropriate health technologies.
e) Contribution to the prevention and control of endemic and epidemic diseases,
and to the management of special Public Health events.
f) Contribution to the development of human resources, in particular in the
technical-professional and scientific areas specific to Health.
g) Carrying out the quality control of laboratory analyses through a laboratory
reference system.
h) Dissemination of information of a technical-scientific nature, for the scientific
community, health workers, and the public in general.
i) Implementation of Health Observations to document the Health Status of the
Population and its Determinants.
j) Formation of partnerships with other national and international institutions for the
execution of research, training, and public health activities.

Article 5 (Competencies)
In order to fulfill its attributions, it is incumbent upon the INS to:
a) Coordinate and oversee the definition of the national health research agenda and
the application of it throughout the national territory;
b) Promote and coordinate national health research development activities, in
particular through institutional strengthening, the scientific training of national
technicians and the monitoring of the research environment in the Health
System;
c) Develop clinical, biomedical, pharmacological, epidemiological, and socio-
anthropological research, based on national priorities.
d) Develop and conduct research in Health Systems as an instrument for the
definition of health policies;
e) Develop and guarantee multi-sectoral and transdisciplinary research, through
related research institutions and other bodies of recognized competence.
f) Promote funding for scientific research activities;
g) Assess the health situation and its determinants;
h) Develop and evaluate technologies applied to disease prevention and control;
i) Contribute to laboratory diagnosis in the face of epidemic outbreaks;
j) Carry out quality control of laboratory analyses through a laboratory reference
system;
k) Ensure biosafety aspects related to the operation of reference laboratories;
l) Conduct postgraduate and continuing education courses for health personnel in
coordination with the Ministries that oversee the areas of Education and Higher
Education;
m) Collaborate with teaching institutions in the training of health care personnel at
medium and higher levels in coordination with the Ministry that supervises the
area of Education.
n) Cooperate with national and foreign scientific institutions and international
development support agencies to promote technology transfer for the formation
and training of national researchers and technicians;
o) Promote actions of technical-scientific dissemination inherent in public health.

Article 6 (Tutelage)
1. The INS is supervised by the Minister who oversees the area of Health.
2. The guardianship includes, in particular, the power to authorize and approve the
following acts:
a) Approval of INS Internal Rules;
b) Homologation of programs, activity plans, and annual reports;
c) Creation of forms of local representation;
d) Inspection of INS bodies, services, and documents;
e) Others resulting from the Law.

Article 7 (Directorate General)


1. The INS is headed by a Director General, assisted by a Deputy Director General, both
appointed by the Prime Minister, on the proposal of the Minister overseeing the area of Health.
2. The Director-General and the Deputy Director-General shall serve for a renewable term
of five (5) years.

Article 8 (Competencies of the Director General)


It is incumbent upon the Director General of INS to:
a) Define the general direction of management and direct the activities of the INS,
with the vision of realizing its attributions, reporting to the Minister of
guardianship.
b) Direct the activity of the external relations of the INS;
c) Represent the INS in and out of court;
d) Submit to the Minister of guardianship the plan and annual report of activities;
e) Superintend the management of the human and financial resources of the INS;
f) Appoint, dismiss, and discharge the heads of the central body, regional
delegations, and other forms of local representation;
g) Carry out the other duties assigned to him by the Minister of guardianship.

Article 9 (Competencies of the Deputy Director General


The Deputy Director General shall:
a) Under the guidance of the Director General, ensure technical and scientific
coordination and integration of INS activities;
b) Assist the Director General in the performance of his duties;
c) Substitute for the Director General with his impediments, in accordance with the
precedence he has defined;
d) Exercise any other powers delegated to him by the Director General.

Article 10 (Bodies)
The INS has the following bodies:
a) The Governing Board is the advisory and management body of the INS;
b) The Consultative Council is the consultation and coordination body of the INS;
c) The Technical-Scientific Council is the multi-sectoral consultation body of the
Directorate General of the INS;
d) The Institutional Scientific Committee is an advisory body to the Directorate
General of INS, regarding the technical-scientific development of the institution;
e) The Institutional Ethics Committee is a technical body that looks after the ethical
aspects of the technical-scientific activities of the INS;
f) The Institutional Biosafety Committee is a technical body that looks after the
biosafety aspects of the technical-scientific activities of the INS.

Article 11 (Funding)
The following constitute the funding of the INS:
a) Appropriations from the State Budget;
b) Proceeds from the provision of services;
c) Proceeds from the sale of publications edited by INS;
d) Subsidies, donations, covenants, or liberalities attributed by any public or private
entities, national or foreign;
e) Any others resulting from the activity of the INS or that are legally awarded to it.

Article 12 (Expenses)
The following constitute expenses of the INS:
a) Charges relating to operations;
b) Costs resulting from the training and management of staff;
c) Costs of acquiring, maintaining, and conserving goods, services, or facilities
necessary for operations and the exercise of attributions.

Article 13 (Personnel)
The INS personnel are governed by the legal regime of the public function, but it is
permissible to conclude labor contracts that are governed by the general regime, whenever this
is compatible with the nature of the function to be performed.

Article 14 (Organic Statute)


It is the responsibility of the Ministry that oversees the area of Health to submit to the
competent body the approval of the Organic Statute of the INS within a period of sixty (60) days
from the date of publication of this Decree.

Article 15 (Implementation)
This Decree shall enter into force on the date of its publication.
Apporoved by the Council of Ministers on September 5, 2017.
Published.
The Prime Minister, Carlos Agostinho do Rosario.

Resolution No. 46/2017


of November 2nd
There being the need to redefine a normative legal framework that institutionalizes the
general lines, philosophy, and strategy of the State in the field of social action in the country,
according to item f) of No. 1 of Article 204 of the Constitution of the Republic, the Council of
Ministers determines:
Article 1. The Social Action Policy and Implementation Strategy, which is an integral part
of this Resolution, is hereby approved.
Article 2. Resolution No. 12/98, of April 9, is revoked.
Article 3. This Resolution shall enter into force on the date of its publication.
Approved by the Council of Minister on August 1, 2017.
Published.
The Prime Minister, Carlos Agostinho do Rosario.
APPENDICES
APPENDIX C. CASE STUDIES OF CREATING LEGAL
FRAMEWORKS FOR NPHIS, AND THE RESULTANT
LAWS, STATUTES, DECREES, OR REGULATIONS

C4. Nigeria Case Study and Law

Appendix C. Case Studies of Creating Legal


PAGE | 77
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
CASE STUDY
Case Series on Providing a Legal Nigeria Centre for Disease Control (NCDC)
Framework for a National Public The NCDC was established in 2011 to improve Nigeria’s
Health Institute: preparedness to handle public health challenges and to
optimize the use of public health resources. The value
The Nigeria Experience of having an NPHI was demonstrated during the 2014
response to the Ebola outbreaks. In 2017, a legal framework
for NCDC was passed by the national legislature. It was
signed by President Buhari in 2018. Because Nigeria is
so large and populous, a decision was made to create a
parastatal organization, which would be more nimble than a
line agency within the Ministry of Health.

Critical Aspects of the Nigeria CDC Establishment Bill


The Bill establishes NCDC as a corporate body that has
properties consistent with those of other corporations.
NCDC is provided a wide range of critical roles.
Prominent are issues related to communicable diseases
and addressing acute public health threats, including
leading Nigeria’s implementation of the International
Health Regulations. Examples of other functions given
to NCDC include providing support to States and Local
Governments, developing and disseminating public health
research to inform policy and guidelines, and maintaining
a network of reference and specialized laboratories. It can
demand information, data, clinical samples, and reports on
communicable and non-communicable diseases of public
health relevance within Nigeria.
The NCDC is governed by a Board, with a Chair appointed
by the President, and the Director General/Chief Executive
Officer of NCDC serves as Secretary to the Board. The
Director General is appointed by the President for a five-
year term and is subject to the supervision of the Board and
the Minister.

Appendix C. Case Studies of Creating Legal


PAGE | 78
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
Legal Mechanism Used
CASE STUDY
The Nigeria CDC Establishment Bill was approved by the
national legislature in 2017 and was signed into law in
November 2018. Within the Nigerian lawmaking process,
there are no Executive Branch options, such as decrees, as
there are in other countries.

Lessons Learned in Creating the Nigeria CDC


Establishment Bill
• The NCDC began functioning in ways consistent with
the Bill before it had been signed by the President.
Staff were recruited and NCDC began conducting the
functions described. Demonstrating effectiveness as an
NPHI, even without an official legal framework, increases
critical support for the NPHI’s functions and for the
creation of a legal framework.
• Input from stakeholders was very useful in the
development of the Bill. For example, the decision to
have NCDC be the International Health Regulations focal
point was arrived at following widespread consultations,
including with WHO.
• Because amending a law or decree can be very time-
consuming, it may be better to leave vague such topics
as the organizational structure or details of the Board’s
functioning so they can be easily modified as the
country’s or organization’s needs change.
• Addressing overlap between functions of the NPHI
and that of other organizations requires a great deal of
discussion and consultation. Another difficult issue was
clarifying at what point responsibility transfers from a
previous organization to the newly created NPHI.
• NCDC has had support both from the Minister of Health,
but also from the President. Having the President back
the NPHI’s creation can overcome otherwise difficult
roadblocks.
We thank Dr. Chikwe Ihekweazu, Chief Executive Officer of
Nigeria CDC, and Oyeronke Oyebanji, Technical Assistant
to the Chief Executive Officer, for their assistance in
developing this case study.

Appendix C. Case Studies of Creating Legal


PAGE | 79
Frameworks for NPHIs, and the Resultant Laws, Statutes, Decrees, or Regulations
PROVIDING A LEGAL FRAMEWORK FOR A NATIONAL PUBLIC HEALTH INSTITUTE (NPHI)
Extraordinary

Federal Republic of Nigeria


Official Gazette
No. 145 Lagos - 12th November, 2018 Vol. 105
Government Notice No. 97
The foHowing is published as Supplement to this Gu::ette:.

Act No. Short Title Page

18 Nigeria Centre for Disease Control and Prevention (Establishment)


Act. 2018 .. Al77-193

Printed and Published by The federal Go,·ernment Printer, Lagos, Nigeria FGP
I 0/0220 ! 9/250

Annual Subscription from I st January.2019 is Local : N45,000.00 Overseas: N60,500.00 [Surface Mai!}
N75,000.00 [Second Class Air Mail]. Present issue N-2.500 per copy. Subscribers who wish to obtain Ga:effe
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A 177
NIGERIA CENTRE FOR D L E CONTROL AND
PREVENTION (ESTABLIS OCIT) ACT, 2018.

ARRANGEMTh'T Of SECTIONS

SECTION :

PART I-OBJECTIVES AND ADMINISTRATION

1. Objectives.
PART II-ESTABLISHMENT AND FUNCTIONS OF THE CENTRE

2 Establishment ofNigeria Centre for Disease Control and Prevention.


3.. Functions of the Centre.
4. Powers of the Centre.
PART III-ESTABLISHMENT AND FUNCTIONS OF THE GOVERNING BOARD

5. Establishment of Governing Board of the Centre.


6. Tenure of office.
7. Remunerations.
8. Cessatioti of membership.
9. Functions and powers of the Board.
PART IV-MANAGEMENT AND STAFF OF THE CENTRE

IO. Operatioi1al structure of the Centre.


11. Appointment oft he Director-General.
12. Other staff of the Centre.
13. Conditions of service.
y_:_FINANCIAL PROVISIONS
PART

·14. Fund of the Centre.


15. Expenditure of the Centre.
16. Acceptance of gifts.
17. Annual estimates.
18. Audit of accounts.
19. Annual reports.
20. Investments. ·
A 178 2018 No.. 18 Nigeria Centre for Disease Control and Prevention
• (Establishment) Act. 2018
PART VI-NATIONAL ADVISORY COUNCIL AND ITS FUNCTIONS.

21'. Establishment of the National Advisory Council.


22. Functions of the National Advisory Council.
pART VII-MiscEi LANEOUS
23. Premises and offices.
24. Power of the Minister to give directives.
25. Regulations.
26. Legal proceedings.
27. Interpretation
. 28 Citation.
SCHEDULE
A 179

NIGERIA CENTRE FOR DISEASE CONTROL AND PREVENTION


(ESTABLISHMENT) ACT, 2018
ACTNo.18
AN ACT TO ESTABLISH THE NIGERIA CENTRE FOR DISEASE CONTROL AND PREVENTION FOR THE PREVENTION,

DETECTION, fNVESTIGATION, MONITORING AND CONTROL OF COMMUNICABLE DISEASES IN NIGERIA ; AND

FOR RELATED MATTERS.

[8th Day ofNovembe1; 2018] Commence- ment.


ENACTED by the National Assembly of the Federal Republic ofNigeria:
PART I-OBJECTIVES. AND ADMINISTRATION

1. The objective ofthisAct is to establish a Centre with the responsibility Objectives.


to-
(a) protect Nigerians from the impact of communicable diseases of
public health importance;
(b) maintain the highest state ofale1tness to detect and respond to disease
outbreaks, public health disasters, mass morbidity and mortality,due to
pathogenic, chemical or biological agents;
(c) develop and coordinate capabilities, measuresand activities to control
outbreaks and mitigate the health impact ofpublic health disasters;
(d) develop and coordinate an ihformation network for the r -p-orting and
notification ofcommunicable diseases;
(e) develop and make accessible guidelines nd standards for relevant public
health activities at all levels in the country;
(l) communicate information to the public on the need to protect
themselves from public health threats as well as health professionals on the need
to safely manage their patients and protect themselves ; and
(g) lead Nigeria's implementation of International Health Regulations and
coordinate its paiticipation in international disease, prevention and control
activities by establishing and maintaining close communication and
collaboration with relevant international health organisations as well as other
countries of the world.
PART fl-ESTABLISHMENT AND fUNCTI0l\S OF THE CENTRE

2.-(l)Thc:n; ist-'_. blishedtheNigeriaCentreforDiseaseControl and Establishment


Frc:vemion On this Act referred to as "the Centre"). ofNigeria
Centre for
(2) The Centre-· Disease Control
(a) isa bodycorporate with perpetualsuccessionanda common seal and Prevention.
A 180 2018 No. 18 Nigeria Centre for Disease Control and Prevention
(Establishment) Act, 2018
(b) may sue and be sued in its corporate name;
(c) may acquire, hold or dispose of property, whether moveable or
immovable; and
(d) may enter into contracts and incure obligations. 3.-

Functions --{1) The Centre shall-


of the
(a) prevent, detect, monitor and control diseases of national and
Centre.
international public health impo1tance, including emerging and re-emerging
diseases;
(b) develop, maintain and coordinate surveillance systems to collect,
analyse and interpret data on diseases of public health impo1tance, in order to
detect public health threats, guide health interventions and set public health
priorities;
(c) lead the response to disease outbreaks, public health emergencies and
disasters in order to minimise the impact on health;
(d) develop and maintain a network of reference and specialised
laboratories for pathogen detection, disease surveillance and outbreak
response;
(e) develop and maintain guideIines and processes for specimen collection and
transpo1tation to reference laboratories including the World Health
Organization (WHO) standard reference laboratories in Nigeria;
(f) conduct, collate, synthesise and disseminate public health r search to
inform policy and guidelines on diseases of public health impo1tance, and put in
place a national public health research agenda and database;
(g) strengthen nati<:mal health information systems to suppo1t prevention and
control measures of communicable diseases;
(h) provide information to the public through multiple platforms on diseases and
publichealth events;
(i) coordinate the operationalisation of, and ongoing international health
regulations, including trans-border disease surveillance and control activities and
lead the collaboration with global health agencies;
(i) provide support and coordinate the control of national and trans-
border respqnses to mass public health emergencies, such as mass casualties, floods,
nuclear, biological and chemical terrorism, disease outbreaks and heavy metals
poisoning;
(k) develop and maintain a communication network with all public health
institutions, with roles in mitigating the impact of diseases;
Nigeria Centre for Disease Control and Prevention 2018 No. 18 A 181
(Establishment) Act, 2018

(/) provide scient1fic guidance for local production of vaccines and other
biological agents such as diagnostic kits, sera and anti-sera, food science and
nutritional products, and other related substances useful for the health services,
through locallydevelopedtechnologyortechnologytransfer;
(m) provide support to the Federal Ministryof Health for the development of
evidence-based guidelines and policies as weHas the implementation of
programmes relating to disease prevention ang control, in line with
international guidelines and recommendations;
(n) provide guidance, technical and logistic support to the States and Local
Governments for the planning, implementation and management of diseases of
public-health impo11ance and on activities to· reduce health risk and impact from
public health events;
(o) provide technical supp01t to relevant government institutions on
environmental health activities, as it relates to disease prevention, control and
emergency disaster response;
(p) provide technical support for health disaster risk-reduction and
management in collaboration with other major stakeholders in the country;
(q) implement relevant decisions ofNational Council on Health as regards
disease control, prevention and disaster management;
(r) serve as the Secretariat to the National Health Emergency
Preparedness and Response Committee;
(s) lead on the training of field epidemiologists through the Nigeria Field
EpidemiologyTrai11ing Programme; ahd
(t) carry out su'ch activities as may be necessary or expedient for the
performance of its'.functions under this Act.
(2) The Centre shall submit annual costed wprk plans relating to its
functions to the Minister for approval.
4. The Centre has powers to-- Po\\·ers of
(a) demand ai1d obtain relevant information, data, clinical samples and the Centre.
report on diseases of public health relevance and control of public health
events, including communicable diseases, emergencies and disasters
occurring withinNigeria;
(b) develop and enforce the use of standards, protocols and guidelines for
disease prevention and control including diagnostics, disease detection and
rep01ting in compliance with international best practices;
(c) collaborate with Po1t-Health Services to operate quarantine services
including inspection, isolation, detection and management of quarantine
stations at points ofentry into Nigeria ;
A 182 2018 No. 1,8 Nigeria Centre for Disease Control and Prevention
(Establishment) Act, 2018
(d) implement and coordi11ate disease detection, prevention and
control activities including international health regulations, surveillance,
disease preparedness and response, capacity building for health workers,
research and ethical standards as it relates to diseases of public health
importance;
(e) coordinate relevant health sectors on the preparation and response
to public healthemergencies and disasters in the country including
networking and liaising with relevant establishments within and
outsideNigeria in pursuance of the functions of the Centre ; and
(f) do all such things as may be necessary for or incidental to the
performance and discharge of its functions and duties under this Act.
PART III-EsTABUSHMENT AND FUNCTIONS OF THE GovERNIJ\G BOARD

Establishment 5.--(1) There is established a Governing Board for the Centre (in this
ofGoverning Act referred to as "the Board") which shall consist of
Board of the
Centre. (a) a chairman, who shall be-
(i) appointed by the President, on the recommendation of the
Minister, and
(ii) a renowned health professio, al of at least I 5 y ears cognate
experience;
(b) a Director-General and Chief Executive Officer who is also the
Secretary to the Board;
(c) the Permanent Secretary of the Federal Ministry responsible for
health;
(d) a representative each, not below the rank of a Director and
with relevant experience, from the Federal Ministry of-
(i) Health,
(ii) Finance,
(iii) Science and Technology,
(v) Agriculture and Rural Development, and
(vi) Environment;
(e) a representative each, not below the rank of a Director and with
relevant experience, from-
(i) National Primary Health Care Development Agency, and
(ii) Armed Forces Medical Services;
(f) a person from the private sector with at least IO years cognitive
experience and knowledge in the field of public health; and
(g) a representative of the Civil Society Organisations.
Nigeria Centre for Disease Control and Prevention 2018 No. 18 A 183
(Establishment) Act, 2018
(2) The members of the Board other than the ex-officio members shall
be appointed by the President on the recommendation of the Minister, and
shall be persons of proven integrity, ability and with cognate experience in
disciplines relevant to the objectives of this Act.
(3) The supplementary provisions set out in the Schedule to this Act shall Schedule.
have effect with respect to the proceedings of the Board and other matters
contained in the Schedule.
6.-( I) The Chairman and the members of the Board, who are not ex- Tenure of
ofj-icio members, shall hold office- Office.

(a) for a term of four years and no more; and


(b) on such terms and conditions as may be specified in their letters of
appointment.
(2) Notwithstanding the provisions of subsection (I) (a), the Chairman
or any member of the Board, may, at any time be removed from office by
the President, for inability to discharge the duty of his office, whether arising
from infirmity of mind or body or any other cause, or misconduct, or in the
public interest.
7. A member of the Board shall be paid such emoluments, allowances Remunerations.
and benefits in line with what is obtainable in other Board as the
President may approve.
8. (I) The office of the Chairman, the Director-General or a member of Cessation of
the Board becomes vacant where- membership.

(a) his term of office expires;


(b) he resigns by a notice in writing addressed to the President;
(c) he dies;
(d) he has been absent from the Board meetings for four
consecutive times without the permissionof the Boaro;.
(e) he becomes of unsound mind or incapable of carrying out his
duties due to physical or mental illness;
(f) he has been-declared bankrupt or makes compromise with his creditors;
(g) he has been convicted of a felony or any offence involving dishonesty;
(h) he is guilty of gross misconduct relating to his duties;
(i) the President directs the removal of the member upon being
satisfied that it is not in the interest of the Centre or of the public for
the person to continue in office as a member of the Board; or
(i) in the case of an ex-officio member, he ceases to hold the office on
the basis of which he became a member of the Board.
A 184 2018 No. 18 Nigeria Centre for Disease Control and Prevention
(Establishment) Act, 201 8
(2) Where a vacancy occurs in the membership of the Board, it shall be filled
by an appointment by the President ofa successor to hold office for the remainder
of the term of office of his predecessor and the successor shall represent the
same interest as that member whose exit created the vacancy.
Functions 9. The Boar shall-
and powers (.a) provide supervisory functions on the affairs of the Centre;
of the
Board. (h) fonnulate the overall policy of the Centre and act in the name of the
Centre;
(c) create pai1nerships and fund raising capabilities for successful project
implementation ;
(d) provide support for engaging the States of the Federation, and other
relevant pm1ners for effective surveillance a11d disease prevention and
control;
(e) supervise the strategic repositioning of the public health system to
enable it respond to and put in place an emergency and pandemic
preparedness_'system, and to efficiently and effectively respond to disease
outbreaks and other public health events;
(f) ensure that adequate technical· systems are in place for the Centre to
form ct ;
(g) estaolishcomi-nitteesasmaybeexpedienttobechargedwithspecific
functions de1egateci by the Board;
.

(h) set the terms and condition's of servic including appointment,


remuneration, promotion and discipline ofemployees of the Centre after
consultation with the Ministry and other relevant authorities; and
(i) do such}6th;r things of a policy nature as may be necessary for
successful performarice ofits functions under this Act.
PART JV-. MANAGEMENT AND STAFF OF THE CENTRE

10. (I) The Centre shall-


Operational·
structure (a) have its corporate office situate at the Federal Capital Territory,
of the Abuja;
Centre. (b) have Zonal Centres in all the six geo political zones of the Federation and
Offices in aH the States of the Federation: and
(c) be designatedas the International Health Regulations National Focal
Point.
(2) The operational structure of the Centre shall comprise-
(a) office of the Director-General ;
Nigeria Centre for Disease Control and Prevention 2018 No. 18 A 185
(Establishment) Act, 2018
(b) seven Departments headed by Directors-
(i) Outbreak Preparedness and Response,
(ii) Health Emergencies Preparedness and Response,
(iii) Epidemiology and Surveillance,
(iv) Planning, Research and Statistics,
(v) Laboratory and Diagnostic Services,
(vi) Finance and Accounts, and
(vii) Human Resources and Administration; and
(c) such other departments as may be required for the proper
performance of the functions of the Centre.
11.--( I) The President shall, on the recommendation of the Appointmen
Minister, appoint a Director-General for the Centre who shall be a health t of the
professional with at least 15 years postgraduatequalification experience in Director-
relevant fields ofmedicine or public health. General.

(2) The Director-General shall be-


(a) the Chief Executive Officer of the Centre and responsible for the
administration of the Centre; and
(b) subject to the supervision of the Board and the Minister.
(3) The Director-General shall hold office for a term of four years on
such terms and conditions as may be specified in his letter of appointment
and be eligible for reappointment for another term of 4 years and no-more
on such terms and conditions as may be determined by the President
on the recommendation of the Minister.
12.--( 1) The Board may appoint such other persons as it considers Other staff
necessary as staff of the Centre and may engage experts to render consultancy of the
services to the Centre, subject to extant Public Service Rules. Centre.

(2) The staff of the Centre shall be public servants as defined in the
Constitution of the Federal Republic of Nigeria, 1999.
(3) The employment of the staff of the Centre shall be subject to
such terms and conditions as may be stipulated by the Board and
contained in the respective staff employment contracts.
13.--( I) The Centre shall develop and implementappropriate conditions Conditions
of service for its staff with particular regard to the issues of remuneration, ofservice.
pension scheme and other service fringe benefits, sufficient for the Centre to
attract and retain quality and high caliber manpower.
A 186 2018 No. 18 Nigeria Centre for Disease Control and Prevention
(Establishment) Act, 2018

Act No. 4 (2) Service in the Centre shall be approved service for the purpose
2014. of the Pensions Reform Act and accordingly employees of the Centre
shall.in respect of their services be entitled topensions, gratuities and other
retirement benefits as are prescribed in the Act.
(3) Notwithstanding subsection (2), nothing in this Act shall prevent
the appointment of a person to any office on terms which preclude the
grant of a pension, gratuity or other retirement benefits.

Act No. 4 (4) For the purpose of the application of the Pensions Reform Act, any
2014. power exercisable by the Minister or other authority of the Government of
the Federation, other than the power to make Regulations under section 2
or 3 of the Act is vested and exercisable by the Board.
PART V-FINANCIAL PROVISIONS

14.--{l) The Centre shall establish and maintain a fund (in this Act
Fund of the
Centre referr,;::d to as "the Fund") from which shall be defrayed all expenditure
incurred by the Centre for the purpose of this Act.
(2) There shall be credited to the Fund-
(a) such sums as may be appropriated to the Centre by the Federal
Government;
(b) fees and charges for services rendered by the Centre;
(c) fees from publications made by the Centre;
(d) such sums accruing to the Centre byway of gifts, grants,
endowments, bequests, donations or voluntary contributions by persons
or organisations;
(e) foreign aid and assistance frommultilateral and bilateral
organisations or agencies;
(f) subventions and extra budgetary allocations accruable from the
Federal Governme1it or any other institution; and
Act No. 8
2014.
(g) 21/2% of the 50% Basic Health Care Provision Fund established
under section 11 (I) of the National Health Act.
Expenditure
15. The Centre sldl apply the proceeds of the Fund at its disposal to-
of the
Centre. (a) the cost of ,,c:ninistration of the Centre;
(b) perform the functions of the Centre under this Act ;
(c) pay members of the Board or any committee set up by the Board
for such expenses as may be expressly authorised by the Board in
accordance with the approved rates ;
(d) the payment of salaries, fees or other remuneration,
allowances, pensions and benefits payable to employees of the
Centre;
Nigeria Centre for Di ease ·Control and Prevention 2018 No. 18 A 187
(Establishment) Act, 2018
(e) publicise and promote the activities of the
Centre;
(f) bui.ld the capacity of staff of the Centre;
(g) conduct and support research activities;
(h) publish scientific findings, health education material, protocols,
guidelines and public healthrules and regulations;
(i) support membership of national or international scientific and
professional organisations, working on Disease Control and Prevention
and pay annual dues and other contributions to such organisations;.
G) support and encourage national non-governmental
organisations, nationwide in the effort to mitigate the impact of
communicable and non- communicable diseases;
(k) build, acquire and maintain any property vested in the Centre;
(l) implement rapid response to public health emergencies and
disasters; and
(m) conduct any other activities relevant to the performance of
its functions under this Act.
16.-{ l) The Centre may accept gifts ofland and money or other Acceptance
property on such terms and conditions, as may be specified by the person or . of gifts.
organisation offering the gift.
(2) The Centre shall not accept any gift if the conditions attached by
the person or organisation offering the gift are inconsistent with the
functions of
· the Centre.
17. The Board shall cause to be prepared and submitted to the Minister, Annual
not later than 30th September of each year, an estimate M the expenditure
estimates
. and income of the Centre for the following year.

. 18. The Board shall keep proper accounts of the Centre in respect of Audit of
each year and proper records in relation thereto and shall causethe account accounts.
to be audited not later than six months after the end of each year by auditors
appointed in accordance with the guidelinesprovided by the Auditor-General
for the Federation.
19. The Board shall, not later than 30th June in each year, prepare and Annual
submit to the Minister a report on the activities and administration of the Centre
reports.
during the preceding year and shall include in the report a copy of the audited
accounts of the Centre for the year and the auditor's report on the accounts.
20.-{ 1) The Centre may, subject to the provisions of this Act and the Investments.
conditions of any trust created in respect of any property, invest any of its
· funds in any security as may be recommended by the Board and approved by
the Minister.
A 188 2018 No. 18 Nigeria Centre for Disease Control and Prevention
(Establishment) Act, 2018.
(2) The Centre is exempted from the payment of income tax on any
incomes derived by it under this Act or accruing to it from any investment.
(3) The Centre is exempted from payment of custom excise and
duties for health commodities (medicines, equipment, etc.) for the purpose
of pul?lic health events and disasters.
pART VI-NATIONAL ADVISORY COUNCIL AND ITS FUNCTIONS
Establishment 21.-(1) There is established for the Centre the National Advisory
of t he Council.
National
Advisory
(2) The National Advisory Council shall consist of nine members with
Council. requisite expertise in public health and social science and shall be
<1ppointed by the Minister.
(3) The Council shall be chaired by a public health professional.

Functions of 22. The National Advisory Council shall-


the National (a) provide high quality scientific and technical advice and guidance
Advisory
Council. to the Centre and assist in its mentoring;
(b) advise on community engagement as it relates to the activities of
the Centre;
(c) advise on how to mobilise international technical and scientific
support ; and
(d) suppo11 resource mobilisation activities of the Centre.
pART VII-MISCELLANEOUS

Premises and
23. For the purpose of providing office premises necessary for the
offices. performance of its functions, the Centre may, subject to the Land Use
Cap. L5 Act-
LFN, 2004.
(a) purchase or take on lease any land, building or property;
(b) build, equip and maintain offices and premises ; or
(c) let, sell or lease out any office or premises held by it, which is no
longer required for the performance of its functions under this Act.
Po,Yer of the
Minister to 24. Subject to the provisions of this Act, the Minister may give the Board
give such directives of a general or special nature relating to the performance
directives. by the Centre of any or all of its functions under this Act, and the Board
shall comply with such directives.
Regulations.
25. The Centre may, with the approval of the Minister, make
regulations and issue guidelines generally for the purpose of giving effect to
the provisions of this Act.
A 189

Nigeria Centre for Disease Control and Preventfon 2018 No. 18


(Esta blishment) Act, 2018 proceedings.
26. :--(1) No suit shall be commenced against the Centre before the Legal
expiration of a period of one month after written notice of intention to
commence the suit has been served upon the Centre by the intending plaintiff or his
agent and the notice shall clearly state the-
( a}--cause of action ;
(b) pa1ticulars ofthe claim ;
(c) _name andplace of abode ofthe intending plaintiff; and
(d}relief which he claims.
(2) The notice referred to in subsection (1) and any summons or other
_ document required or authorised to be served upon the Centre under this Act
_ or any other enactment or law may be served by-
(a) delivering it to the Director-General; and
(b) sending it by registered post addressed to the Director-General at the
Head Office of the Centre.
(3) In any action or suit against the Centre, no execution or attachment
process in that nature shall be issued against the Centre without the consent of the
Attorney-General of the Federation.
(4) Notwithstanding the provision of subsection (3), any sum of money
.- which may, by thejudgment of the comt be awarded against the Centre, shall,
· · . subject to any direction given by the Centre, be paid from the general reserve
. of the Centre. Interpretation.

27; In this Act-


"Board'' means the Governing Board of the Centre;
"function" includes duties and powers ;
"Member" means a member of the Governing Board and i11cludes the
Chairman
"Minister" means the Minister charged with the responsibility for
health;
"Ministry" means the Ministry charged with.the responsibility for health
matters ; and
"President" means the President of the Federal Republic ofNigeria.
28. This Act may be cited as the Nigeria Centre for Disease Control Citation.
and Pre\ ention (Estabiishment) Act, 2018.
1
A 190 2018 No. 18 Nigeria Centre for Disease Control and Pre,,ention
(Establishment) Act, 2018
SCHEDULE Section 5 (3)

SUPPLEMENTARY PROVISIONS RELATING TO THE BOARD

Proceedings of the Board


1. Subject to this Act and section 27 of the Interpretation Act, the Board
may regulate its proceedings and make standing orders with respect to the
holding ofits meetings, and those of its committees, notices to be given, the
keeping ofminutes ofits proceedings, the custody and production for inspection of
such minutes and such other matters as the Board may determine.
2. There shall be at least four meetings of the Board in every calendar year
but the Board shall meet whenever it is convened by the Chairman, and ifthe
Chairman is requested to do so by notice given to him by not less than six other
members, he shall convene a meeting of the Board to be held within 30 days from
the date on which the notice was given.
3. Every meeting of the Board shall be presided over by the Chairman and,
ifhe is unable to attend a particular meeting, the members present shall elect one
of them to preside at the meeting.
4. The quorum ofany meeting of the Board shall be the Chairman (or in an
appropriate case, the person presiding under paragraph 2) and six other
members.
5. A question put before the Board at a meeting shall be decided by
consensus and where this is not possible, by a majority of the votes of the
members present and voting.
6. The Chairman shall, in the case ofan equality ofvotes, have a casting
vote.
7. Where the Board seeks the advice of any person on a paiticular
matter; the Board may invite that person to attend for such period as it deems fit,
but the person is not entitled to vote at any meeting of the Board and does not
count towards the quorum.
8. The Board shall meet for the conduct ofits business at such places and
on such days as the Chairman may appoint.
Committees
9. The Board may set up one or more committees to perform, on behalf of
the Board, such functions as the Board may determine and rep01t on any matter
with which the Board is concerned.
Nigeria Centre for Disease Control and Prevention 2018 No.18 A 191
(Establishment) Act, 2018

10. A committee set up under paragraph 9 shall be presided over by a


member of the Board and shall consist of such number of persons (not
necessarily all members of the Board) as, may be determined by the Board and a
person other than a member of the Board shall hold office on the committee
in accordance with the terms of his appointment.
11. Adecision of a committee of the Board is of no effect_until the Board
confirms it.
Miscellaneous
12. The signature of the Chairman and the Secretary to the Board shall
authenticate the fixing of the seal of the Centre.
13. A contract or an instrument, which if made or executed by any
person not being a body corporate would not be required to be under seal, may be
made or executed on behalf of the Centre by the Director-General or by any
person generally or specificallyauthorisedtoactforthatpurpose by the Board.
14. A document purporting to be a contract, an instrument or other
document signed or sealed on behalf of the Centre shall be received inevidence and is,
until the c01itrary is proved, presumed without further proof, to have been
properly signed or sealed.
15. The validity of any proceeding of the Board or its committee is not
affected by-
(a) any vacancy in the membership of the Board or its committees;
(b) reason that a person not entitled to do so took part in the
proceedings ; or
(c) any defect in the appointment of a member.
16. Any member of the Board or committee who has a personal interest in
any co tract or arrangement entered into or proposed to be considered by the
Board or any committee shall-
(a) disclose his interest to the Board or committee; and
(b) not vote on any question relating to the arrangement.
A 192 2018 No. 18 Nigeria Centre for Disease Control and Prevention
(Establishment) Act, 2018

I certify, in accordance with Section 2 (I) of the Acts Authentication Act, Cap.
A2, Laws of the Federation of Nigeria 2004, that this is a true copy of the Bill
passed by both Houses of the National Assembly.

MOHAMMED ATABA SANI-OMOLORI


Clerk to the National Assembly
5th Day of Octobe1: 2018

EXPLANATORY MEM0RANDU\1

This Act establishes the Nigeria Centre for Disease Control and
Prevention to promote, coordinate and facilitate the prevention, detection and
control ofcommunicable diseases in Nigeria and other events of public health
importance.
SCHEDULE TO THE CENTRE FOR DISEASE CONTROL AND PREVENTION (ESTABLISHMENT) BILL, 2018 ·

(2) (4) (5)


Short Title long Title <d' the Summary <d' the Date Passed hy Date Passed hy
Bill the Senate

Nigeria Centre An Act to establish the Nigeria This Act establishes the Nigeria 17th July, 2018.
for Disease Centre for Disease Control and Centre for Disease Control and 2018.
Control and Prevention ; for the prevention,
Prevention and facilitate the prevention,
(Establishment) and control of communicable detection and control of
Bill,2018. diseases in Nigeria; and for related
matters. and other events of public health
importance.
I certify that this Bill has been carefully compared by me with the decision reached by the National Assembly and found by me to be
true and correct decision of the Houses and is in accordance with the provisions of the Acts Authentication Act Cap. A2, Laws of
the Federation of Nigeria, 2004.
1· ASSI\NT
MOllt\MMl·D ATt\llt\ St\NI-0MOI.ORI

@
Clerk to the National Assembly
5th Day <?/' October, 2018.

Ml!llt\MMt\DlJ Bl!llt\RI, GCFR


President of the Federal Republic <d' NiKeria
8th Day <d' November, 2018.

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